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1.
BMJ Open Qual ; 11(2)2022 May.
Article in English | MEDLINE | ID: covidwho-1874570

ABSTRACT

BACKGROUND: Preterm infants may remain in neonatal intensive care units (NICUs) to receive proper nutrition via nasogastric tube feedings. However, prolonged NICU stays can have negative effects for the patient, the family and the health system. AIM: To demonstrate how a patient-centred, design thinking informed approach supported the development of a pilot programme to enable earlier discharge of preterm babies. METHOD: We report on our design thinking-empathy building approach to programme design, initial outcomes and considerations for ongoing study. RESULTS: Through the use of design thinking methods, we identified unique needs, preferences and concerns that guided the development of our novel early discharge programme. We found that stable, preterm infants unable to feed by mouth and requiring nasogastric tubes can be cared for at home with remote patient monitoring and telehealth support. In addition, novel feeding strategies can help address parental preferences without compromising infant growth. CONCLUSION: A patient-centred, design thinking informed approach supported the development of a pilot programme to enable earlier discharge of preterm babies. The programme resulted in a reduced length of stay, thereby increasing NICU bed capacity and limiting hospital turn-aways.


Subject(s)
Intensive Care Units, Neonatal , Patient Discharge , Hospitals , Humans , Infant , Infant, Newborn , Infant, Premature , Parents
2.
Nestle Nutr Inst Workshop Ser ; 96: 57-71, 2021.
Article in English | MEDLINE | ID: covidwho-1840675

ABSTRACT

Donor milk (DM) is of increasing interest as primary nutritional source for preterm infants. Safe access requires special infrastructure, trained staff, sophisticated algorithms, and standard operating procedures as well as quality control measures. DM has limitations like low protein content and unpredictable composition of the other macronutrients, despite fortification frequently not meeting recommendations - both of them compromising growth. The first paragraph is devoted to COVID-19 and how it impacts processes of DM banking. The following paragraphs review aspects of "pasteurization," "safety audits/donor screening," and "DM nutrient variability." In summary, (i) Holder pasteurization still is the most suitable procedure for milk banks, but high-pressure pasteurization or ultraviolet C irradiation conserve the unique properties of DM better and deserve more research to make it suitable for clinical routine. (ii) In regard to safety/screening, guidelines are valuable for safe DM bank operation, but they differ between legislations. There is a surprisingly high rate of non-disclosed donor smoking (0.3%, p > 0.05) and of adulteration of delivered DM (up to 2%, p < 0.05) not detected by standard donor screening procedures. Frequencies differ between remunerated and non-remunerated programs. (iii) Neonatal caregivers should be aware of unpredictable composition of DM. They should be trained on how these can be overcome to avoid negative impact on growth and long-term outcomes like (a) measuring and disclosing nutrient contents of delivered DM batches to customers, (b) implementing certain types of donor pooling to reduce the risk of macronutrient depleted DM, (c) additional supplementation using 0.3-0.5 g protein/100 mL seems to be reasonable, (d) adjusted fortification may help to improve growth, but is not efficient in all preterm infants, (e) target fortification seems to improve growth (and probably also neurodevelopmental index) compared to standard fortification, (f) more research and clinical studies are needed.


Subject(s)
COVID-19 , Milk Banks , Humans , Infant , Infant, Newborn , Infant, Premature , Milk, Human/chemistry , Pasteurization/methods
3.
Cochrane Database Syst Rev ; 11: CD012778, 2021 11 30.
Article in English | MEDLINE | ID: covidwho-1813439

ABSTRACT

BACKGROUND: Preterm infants are at risk of lung atelectasis due to various anatomical and physiological immaturities, placing them at high risk of respiratory failure and associated harms. Nasal continuous positive airway pressure (CPAP) is a positive pressure applied to the airways via the nares. It helps prevent atelectasis and supports adequate gas exchange in spontaneously breathing infants. Nasal CPAP is used in the care of preterm infants around the world. Despite its common use, the appropriate pressure levels to apply during nasal CPAP use remain uncertain. OBJECTIVES: To assess the effects of 'low' (≤ 5 cm H2O) versus 'moderate-high' (> 5 cm H2O) initial nasal CPAP pressure levels in preterm infants receiving CPAP either: 1) for initial respiratory support after birth and neonatal resuscitation or 2) following mechanical ventilation and endotracheal extubation. SEARCH METHODS: We ran a comprehensive search on 6 November 2020 in the following databases: CENTRAL via CRS Web and MEDLINE via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-randomized trials. SELECTION CRITERIA: We included RCTs, quasi-RCTs, cluster-RCTs and cross-over RCTs randomizing preterm infants of gestational age < 37 weeks or birth weight < 2500 grams within the first 28 days of life to different nasal CPAP levels. DATA COLLECTION AND ANALYSIS: We used the standard methods of Cochrane Neonatal to collect and analyze data. We used the GRADE approach to assess the certainty of the evidence for the prespecified primary outcomes. MAIN RESULTS: Eleven trials met inclusion criteria of the review. Four trials were parallel-group RCTs reporting our prespecified primary or secondary outcomes. Two trials randomized 316 infants to low versus moderate-high nasal CPAP for initial respiratory support, and two trials randomized 117 infants to low versus moderate-high nasal CPAP following endotracheal extubation. The remaining seven studies were cross-over trials reporting short-term physiological outcomes. The most common potential sources of bias were absent or unclear blinding of personnel and assessors and uncertain selective reporting. Nasal CPAP for initial respiratory support after birth and neonatal resuscitation None of the six primary outcomes prespecified for inclusion in the summary of findings was eligible for meta-analysis. No trials reported on moderate-severe neurodevelopmental impairment at 18 to 26 months. The remaining five outcomes were reported in a single trial. On the basis of this trial, we are uncertain whether low or moderate-high nasal CPAP levels improve the outcomes of: death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (PMA) (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.56 to 1.85; 1 trial, 271 participants); mortality by hospital discharge (RR 1.04, 95% CI 0.51 to 2.12; 1 trial, 271 participants); BPD at 28 days of age (RR 1.10, 95% CI 0.56 to 2.17; 1 trial, 271 participants); BPD at 36 weeks' PMA (RR 0.80, 95% CI 0.25 to 2.57; 1 trial, 271 participants), and treatment failure or need for mechanical ventilation (RR 1.00, 95% CI 0.63 to 1.57; 1 trial, 271 participants). We assessed the certainty of the evidence as very low for all five outcomes due to risk of bias, a lack of consistency across multiple studies, and imprecise effect estimates. Nasal CPAP following mechanical ventilation and endotracheal extubation One of the six primary outcomes prespecified for inclusion in the summary of findings was eligible for meta-analysis. On the basis of these data, we are uncertain whether low or moderate-high nasal CPAP levels improve the outcome of treatment failure or need for mechanical ventilation (RR 1.52, 95% CI 0.92 to 2.50; 2 trials, 117 participants; I2 = 17%; risk difference 0.15, 95% CI -0.02 to 0.32; number needed to treat for an additional beneficial outcome 7, 95% CI -50 to 3). We assessed the certainty of the evidence as very low due to risk of bias, inconsistency across the studies, and imprecise effect estimates. No trials reported on moderate-severe neurodevelopmental impairment at 18 to 26 months or BPD at 28 days of age. The remaining three outcomes were reported in a single trial. On the basis of this trial, we are uncertain whether low or moderate-high nasal CPAP levels improve the outcomes of: death or BPD at 36 weeks' PMA (RR 0.87, 95% CI 0.51 to 1.49; 1 trial, 93 participants); mortality by hospital discharge (RR 2.94, 95% CI 0.12 to 70.30; 1 trial, 93 participants), and BPD at 36 weeks' PMA (RR 0.87, 95% CI 0.51 to 1.49; 1 trial, 93 participants). We assessed the certainty of the evidence as very low for all three outcomes due to risk of bias, a lack of consistency across multiple studies, and imprecise effect estimates.  AUTHORS' CONCLUSIONS: There are insufficient data from randomized trials to guide nasal CPAP level selection in preterm infants, whether provided as initial respiratory support or following extubation from invasive mechanical ventilation. We are uncertain as to whether low or moderate-high nasal CPAP levels improve morbidity and mortality in preterm infants. Well-designed trials evaluating this important aspect of a commonly used neonatal therapy are needed.


Subject(s)
Bronchopulmonary Dysplasia , Continuous Positive Airway Pressure , Humans , Infant , Infant, Newborn , Infant, Premature , Morbidity , Respiration, Artificial
4.
Cochrane Database Syst Rev ; 8: CD005249, 2021 08 04.
Article in English | MEDLINE | ID: covidwho-1813434

ABSTRACT

BACKGROUND: Many small, sick, and preterm infants are unable to co-ordinate sucking, swallowing, and breathing, and therefore require gavage feeding. In gavage feeding, milk feeds are delivered through a tube passed via the nose or the mouth into the stomach. Intermittent bolus milk feeds may be administered by a syringe to gently push milk into the infant's stomach (push feed). Alternatively, milk can be poured into a syringe attached to the tube and allowed to drip in by gravity (gravity feed). OBJECTIVES: To determine whether use of push feeding compared with gravity feeding results in more rapid establishment of full gavage feeds without increasing adverse events among preterm or low birth weight infants, or both, who require intermittent bolus tube feeding. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 30 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs comparing push versus gravity intermittent gavage tube feeding in preterm (less than 37 weeks' gestation) or low birth weight (less than 2500 grams) infants, or both. DATA COLLECTION AND ANALYSIS: We assessed the methods of trials regarding blinding of randomisation and outcome measurement. We evaluated treatment effects with a fixed-effect model using risk ratio (RR), relative risk reduction, risk difference (RD), and number needed to treat for an additional beneficial outcome (NNTB) for categorical data; and using mean, standard deviation, and mean difference (MD) for continuous data. We analysed outcomes measured as count data, for example, frequency of apnoea, bradycardia, and episodes of pulse oximeter oxygen (SpO2) desaturation, by comparing rates of events and the rate ratio. We evaluated heterogeneity to help determine the suitability of pooling results. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: One small cross-over trial (31 infants) met the criteria for inclusion in this review. The certainty of evidence for all outcomes was very low due to imprecision of estimates, wide confidence intervals, and unclear risk of bias. The primary outcome - time taken to establish full gavage feeding (days) and feeding intolerance (number of episodes per day) - was not reported in the included study. The evidence is very uncertain about the effects of push versus gravity intermittent gavage tube feeding on all other outcomes. Investigators reported respiratory rate (breaths per minute) at completion of feeding (MD 0.58, 95% confidence interval (CI) -5.97 to 7.13; 1 study, 31 participants; very low-certainty evidence); respiratory rate (breaths per minute) 10 to 30 minutes after completion of feeding (MD 3.1, 95% CI -3.43 to 9.63; 1 study, 31 participants; very low-certainty evidence); heart rate (beats per minute) at completion of feeding (MD 2.6, 95% CI -9.71 to 4.51; 1 study, 31 participants; very low-certainty evidence); and heart rate (beats per minute) 10 to 30 minutes after completion of feeding (MD 2.4, 95% CI -9.16 to 4.36; 1 study, 31 participants; very low-certainty evidence). We are very uncertain of the effects of push versus gravity intermittent gavage feeding on respiratory rate during and after feeding. AUTHORS' CONCLUSIONS: We do not have sufficient evidence to determine the effects of intermittent bolus gavage feeding for preterm and low birth weight infants. The single small study of 31 infants comparing effects of push versus gravity bolus gavage feeding did not report the primary outcome identified in this review. Thus, evidence is insufficient to show whether use of push compared with gravity gavage feeding results in more rapid establishment of full gavage feeds without increasing adverse events in preterm or low birth weight infants who receive intermittent bolus gavage feeding. In addition, the included study was too small to measure potential adverse events that can occur during gavage tube feeding, for example, episodes of oxygen desaturation, apnoea, or bradycardia.


Subject(s)
Enteral Nutrition , Infant, Low Birth Weight , Animals , Cross-Over Studies , Humans , Infant , Infant, Newborn , Infant, Premature , Milk
5.
Eur Rev Med Pharmacol Sci ; 26(7): 2610-2626, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1811983

ABSTRACT

Pregnant women and their infants are at high risk to develop a severe COVID-19, with increased rates of hospitalisation to intensive care units, need for mechanical ventilation and mortality. Preterm birth, fetal vascular malperfusion, and premature rupture of membrane have been the most reported adverse pregnancy outcomes and these effects have been especially associated with the onset of the disease at early gestational age. The early expression of ACE2 and TMPRSS2 in human embryos has been proven, determining an increased susceptibility to SARS-CoV-2. Preterm infants born to women infected by SARS-CoV-2 have a higher risk of need for specialist neonatal care with prolonged hospitalization. Moreover, inflammation of developing embryos could cause long-term defects, regardless of vertical transmission of SARS-CoV-2. Due to Maternal Immune Activation (MIA), in utero inflammation is associated with neurodevelopmental, cognitive and psychiatric disorders in affected offspring. Despite risks that COVID-19 could induce in pregnancy, there are not many published data describing the safety and/or efficacy of COVID-19 vaccines in pregnant women, commonly not included in vaccine research. The evidence from the few pregnant women unintentionally enrolled in clinical trials and vaccinated suggests that COVID-19 vaccines, both based on mRNA and viral vectors, do not pose significant risks to the fetus or breastfeeding infants. Moreover, human studies using mRNA-based vaccines against Zika virus, influenza, and rabies have reported good safety and immunogenicity during pregnancy. In this review, we evaluate the role of COVID-19 in adverse pregnancy and neonatal outcomes and the need to vaccinate pregnant women.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Premature Birth , Zika Virus Infection , Zika Virus , COVID-19/prevention & control , COVID-19 Vaccines , Female , Humans , Infant, Newborn , Infant, Premature , Inflammation , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Pregnancy Outcome , RNA, Messenger , SARS-CoV-2 , Vaccination
6.
Transfusion ; 62(5): 982-999, 2022 05.
Article in English | MEDLINE | ID: covidwho-1807279

ABSTRACT

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. STUDY DESIGN AND METHODS: The US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program. RESULTS: The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). CONCLUSIONS: The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.


Subject(s)
Blood Donors , COVID-19 , Blood Safety , COVID-19/epidemiology , Child , Humans , Infant , Infant, Newborn , Infant, Premature , Longevity , Retrospective Studies , SARS-CoV-2
7.
BMJ Open ; 12(4): e056856, 2022 04 07.
Article in English | MEDLINE | ID: covidwho-1784823

ABSTRACT

OBJECTIVES: The COVID-19 pandemic has disrupted healthcare systems, challenging neonatal care provision globally. Curtailed visitation policies are known to negatively affect the medical and emotional care of sick, preterm and low birth weight infants, compromising the achievement of the 2030 Development Agenda. Focusing on infant and family-centred developmental care (IFCDC), we explored parents' experiences of the disruptions affecting newborns in need of special or intensive care during the first year of the pandemic. DESIGN: Cross-sectional study using an electronic, web-based questionnaire. SETTING: Multicountry online-survey. METHODS: Data were collected between August and November 2020 using a pretested online, multilingual questionnaire. The target group consisted of parents of preterm, sick or low birth weight infants born during the first year of the COVID-19 pandemic and who received special/intensive care. The analysis followed a descriptive quantitative approach. RESULTS: In total, 1148 participants from 12 countries (Australia, Brazil, Canada, China, France, Italy, Mexico, New Zealand, Poland, Sweden, Turkey and Ukraine) were eligible for analysis. We identified significant country-specific differences, showing that the application of IFCDC is less prone to disruptions in some countries than in others. For example, parental presence was affected: 27% of the total respondents indicated that no one was allowed to be present with the infant receiving special/intensive care. In Australia, Canada, France, New Zealand and Sweden, both the mother and the father (in more than 90% of cases) were allowed access to the newborn, whereas participants indicated that no one was allowed to be present in China (52%), Poland (39%), Turkey (49%) and Ukraine (32%). CONCLUSIONS: The application of IFCDC during the COVID-19 pandemic differs between countries. There is an urgent need to reconsider separation policies and to strengthen the IFCDC approach worldwide to ensure that the 2030 Development Agenda is achieved.


Subject(s)
COVID-19 , Pandemics , COVID-19/epidemiology , Cross-Sectional Studies , Female , Humans , Infant , Infant, Newborn , Infant, Premature , Intensive Care Units, Neonatal , Parents/psychology , Surveys and Questionnaires
9.
J AAPOS ; 26(2): 58.e1-58.e7, 2022 04.
Article in English | MEDLINE | ID: covidwho-1751065

ABSTRACT

PURPOSE: To synthesize the literature assessing the diagnostic accuracy of telemedicine evaluation compared with clinical examination for retinopathy of prematurity (ROP) in premature infants. METHODS: Covidence software was used to conduct a systematic literature search from September 14, 2020, through September 27, 2020, on MEDLINE (Ovid), EMBASE (Ovid), CINAHL, and the gray literature to identify studies relevant to telemedicine utilization for ROP detection. After duplicate removal and two-levels of screening, studies comparing telemedicine evaluation with binocular indirect ophthalmoscopic examination were included. Risk of bias assessment was conducted for the included studies following data extraction. A qualitative review was performed to summarize estimates of accuracy of ROP evaluation by telemedicine. RESULTS: A total of 507 studies were reviewed, of which 323 were found in EMBASE, 115 in MEDLINE, and 79 in CINAHL. Three possibly relevant conference abstracts were found. Following duplicate removal, 410 studies were reviewed based on titles and abstracts. Subsequently, 19 articles were thoroughly examined, and 14 studies (2,655 participants) were included. Most studies found that telemedicine performance for detecting ROP was comparable to ophthalmic examination, especially with regard to identifying treatment-requiring ROP. CONCLUSIONS: Telemedicine evaluation can reliably detect ROP. Incorporation of telemedicine into conventional neonatal care has the potential to improve access to ROP care.


Subject(s)
Retinopathy of Prematurity , Telemedicine , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Premature , Ophthalmoscopy , Retinopathy of Prematurity/diagnosis
10.
PLoS One ; 17(3): e0265147, 2022.
Article in English | MEDLINE | ID: covidwho-1745312

ABSTRACT

PURPOSE: To investigate changes in the number of preterm infants, low birth weight infants, and infants with fetal growth restriction (FGR) or retinopathy of prematurity (ROP) during the coronavirus disease 2019 (COVID-19) pandemic. METHODS: In this retrospective cross-sectional study, we reviewed the medical records of infants born and admitted to the neonatal intensive care unit and growth care unit of Shiga University of Medical Science Hospital before the COVID-19 pandemic (April 1, 2019 to September 30, 2019) and during the pandemic (April 1, 2020 to September 30, 2020). Medical records of infants' mothers were also collected. Preterm infants, low birth weight infants, infants with FGR, infant and maternal factors associated with FGR, and infants requiring treatment for ROP were compared between the two periods. RESULTS: There were fewer infants born at < 28 weeks of gestation, infants with birth weight < 1,500 g, and infants with FGR during the pandemic period than the pre-pandemic period (pre-pandemic: n = 4 vs. during pandemic: n = 0, P = 0.048; pre-pandemic: n = 15 vs. during pandemic: n = 6, P = 0.02; and pre-pandemic: n = 31 vs. during pandemic: n = 12, P = 0.0002, respectively). There were no significant differences in any infant or maternal factors associated with FGR. The number of infants requiring treatment for ROP decreased during the pandemic, although this difference was not statistically significant (pre-pandemic: n = 3 vs. during pandemic: n = 0, P = 0.08). CONCLUSIONS: Our findings showed a reduction in the number of infants with FGR during the COVID-19 pandemic. The number of infants born at < 28 weeks of gestation and infants with birth weight < 1,500 g also decreased during the pandemic period. There was a trend toward fewer infants requiring treatment for ROP during the COVID-19 pandemic.


Subject(s)
COVID-19/epidemiology , Fetal Growth Retardation/epidemiology , Infant, Premature , Retinopathy of Prematurity/epidemiology , Birth Weight , Cross-Sectional Studies , Female , Gestational Age , Humans , Infant, Low Birth Weight , Infant, Newborn , Intensive Care Units, Neonatal , Japan/epidemiology , Male , Retrospective Studies
11.
Pediatrics ; 149(6)2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-1724953

ABSTRACT

Information regarding severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in premature infants remains limited. Early in the pandemic, several studies reported that the risk of infection in infants was relatively small and that affected infants had a milder disease than what was seen in adults. Since the increase of the delta variant (SARS-CoV-2 B.1.617.2) within the population, there have been increased reports of more severe disease in infants. We present 3 cases of premature, very low birth weight infants with confirmed SARS-CoV-2 infection who presented with significant hyperglycemia and bone marrow dysfunction. Two infants had presumed vertical transmission, and 1 infant was infected by respiratory transmission. Despite the mode of transmission, symptom onset and duration were similar in all infants. All resolved with symptomatic management. In the context of the continuing pandemic, evaluation for SARS-CoV-2 infection should be considered in premature very low birth weight infants who demonstrate certain patterns of acute metabolic and hematologic abnormalities.


Subject(s)
COVID-19 , Hyperglycemia , Leukopenia , Pregnancy Complications, Infectious , Premature Birth , Thrombocytopenia , Adult , COVID-19/diagnosis , Female , Humans , Hyperglycemia/diagnosis , Infant , Infant, Newborn , Infant, Premature , Infectious Disease Transmission, Vertical , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Outcome/epidemiology , Premature Birth/epidemiology , SARS-CoV-2
12.
N Engl J Med ; 386(9): 837-846, 2022 03 03.
Article in English | MEDLINE | ID: covidwho-1721750

ABSTRACT

BACKGROUND: Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain. METHODS: We randomly assigned, in a 2:1 ratio, infants who had been born at a gestational age of at least 35 weeks to receive a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. The primary efficacy end point was medically attended RSV-associated lower respiratory tract infection through 150 days after the injection. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after the injection. RESULTS: A total of 1490 infants underwent randomization: 994 were assigned to the nirsevimab group and 496 to the placebo group. Medically attended RSV-associated lower respiratory tract infection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group; these findings correspond to an efficacy of 74.5% (95% confidence interval [CI], 49.6 to 87.1; P<0.001) for nirsevimab. Hospitalization for RSV-associated lower respiratory tract infection occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy, 62.1%; 95% CI, -8.6 to 86.8; P = 0.07). Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group. Serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo. CONCLUSIONS: A single injection of nirsevimab administered before the RSV season protected healthy late-preterm and term infants from medically attended RSV-associated lower respiratory tract infection. (Funded by MedImmune/AstraZeneca and Sanofi; MELODY ClinicalTrials.gov number, NCT03979313.).


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antiviral Agents/therapeutic use , Infant, Premature, Diseases/prevention & control , Infant, Premature , Respiratory Syncytial Virus Infections/prevention & control , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Antiviral Agents/administration & dosage , Antiviral Agents/adverse effects , Drug Administration Schedule , Female , Humans , Infant , Infant, Newborn , Injections, Intramuscular , Kaplan-Meier Estimate , Male
14.
Pediatr Infect Dis J ; 41(5): e233-e234, 2022 05 01.
Article in English | MEDLINE | ID: covidwho-1713766

ABSTRACT

Severe coronavirus disease 2019 (COVID-19) occurs in approximately 10% of neonates infected with severe acute respiratory syndrome coronavirus 2. Guidelines for optimal management of severe COVID-19 in neonates do not exist. In this report, we describe a late-preterm neonate with severe COVID-19, requiring invasive mechanical ventilation who recovered following treatment with remdesivir and high dose dexamethasone.


Subject(s)
COVID-19 , Respiratory Insufficiency , Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , COVID-19/drug therapy , Humans , Infant , Infant, Newborn , Infant, Premature , SARS-CoV-2
15.
BMJ Open ; 12(2): e054952, 2022 Feb 22.
Article in English | MEDLINE | ID: covidwho-1706832

ABSTRACT

PURPOSE: The risk of developing asthma-like symptoms and asthma in childhood is influenced by genetics, environmental exposures, prenatal and early postnatal events, and their interactions. The cohort name refers to vitamins A and D, and nitric oxide (NO) spelt backwards and this cohort profile paper aims to present the data collection and aim of the cohort.The overall aim when establishing this cohort was to investigate if childhood lung function can be traced back to early neonatal lung function and fractional exhaled NO (FeNO) and investigate prenatal and postnatal risk factors including maternal and neonatal vitamin A and D levels in preterm and term born children. PARTICIPANTS: One thousand five hundred women and their babies born at Nordsjaellands Hospital in Denmark from 2013 to 2014 were included in the AD-ON research biobank prior to birth.Neonates from the AD-ON research biobank, admitted to the Neonatal Intensive Care Unit at Nordsjaellands Hospital, were included in the AD-ON neonatal cohort. The neonatal cohort consisted of 149 neonates hereof 63 preterm and 86 term born. The children in the cohort have been invited to follow-up visits at age 1 and 6 years. FINDINGS TO DATE: Published data from this cohort includes a validated and clinically applicable method to measure FeNO in neonates. We found an age-specific pattern of association between respiratory symptoms at age 1 and neonatal FeNO in preterm children. Moreover, we found that the respiratory symptoms risk was associated with postnatal factors (Respiratory Syncytial Virus infection and parental smoking) in preterm infants and prenatal factors (parental asthma and maternal infection during pregnancy) in term born infants. FUTURE PLANS: In the future, the children will be examined continuously with 3-year to 5-year intervals until the age of 18. Lung function, allergy tests, environmental exposure measurements and questionnaires will be collected at each follow-up visit.


Subject(s)
Asthma , Nitric Oxide , Asthma/epidemiology , Child , Child, Preschool , Denmark/epidemiology , Female , Humans , Infant , Infant, Newborn , Infant, Premature , Lung , Pregnancy , Vitamin A , Vitamins
16.
Curr Opin Pediatr ; 34(2): 170-177, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1672398

ABSTRACT

PURPOSE OF REVIEW: For over a decade, the International Liaison Committee on Resuscitation has recommended delayed cord clamping (DCC), but implementation has been variable due to lack of consensus on details of technique and concerns for risks in certain patient populations. This review summarizes recent literature on the benefits and risks of DCC in term and preterm infants and examines alternative approaches such as physiologic-based cord clamping or intact cord resuscitation (ICR) and umbilical cord milking (UCM). RECENT FINDINGS: DCC improves hemoglobin/hematocrit among term infants and may promote improved neurodevelopment. In preterms, DCC improves survival compared to early cord clamping; however, UCM has been associated with severe intraventricular hemorrhage in extremely preterm infants. Infants of COVID-19 positive mothers, growth-restricted babies, multiples, and some infants with cardiopulmonary anomalies can also benefit from DCC. Large randomized trials of ICR will clarify safety and benefits in nonvigorous neonates. These have the potential to dramatically change the sequence of events during neonatal resuscitation. SUMMARY: Umbilical cord management has moved beyond simple time-based comparisons to nuances of technique and application in vulnerable sub-populations. Ongoing research highlights the importance of an individualized approach that recognizes the physiologic equilibrium when ventilation is established before cord clamping.


Subject(s)
COVID-19 , Infant, Premature , COVID-19/prevention & control , Female , Hematocrit , Hemoglobins , Humans , Infant, Newborn , Pregnancy , Pregnancy Complications, Infectious , Resuscitation , SARS-CoV-2 , Time Factors , Umbilical Cord/physiology , Umbilical Cord/surgery
17.
Infant Ment Health J ; 43(1): 100-110, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1611238

ABSTRACT

Multiple changes and stressors at the family, hospital, and societal levels have resulted from the COVID-19 pandemic that impact the early social environment of infants in Neonatal Intensive Care Unit (NICU) settings. This manuscript reviews these pandemic-related adversities, including hospital-wide visitor restrictions, mask requirements that interfere with caregiver facial expressions, parental anxiety about virus transmission, and reduced support services. We will further describe adaptations to mental health service delivery and approaches to care in the NICU to mitigate increased risk associated with pandemic-related adversities. Adaptations include integration of technology, staff education and support, and delivery of activity kits to encourage parent-infant bonding. Data was collected as part of routine program evaluation of infant mental health services from one 50-bed NICU setting and describes family concerns, barriers to visitation, and utilization of mental health services during the pandemic. Concerns related to COVID-19 rarely emerged as the primary presenting issue by the families referred for infant mental health services from April through December of 2020. However, a number of families indicated that infection concerns and visitation restrictions posed significant challenges to their parenting and/or coping. There were significant discrepancies noted between the visitation patterns of families with public and private insurance. Several adaptations were developed in response to the multiple challenges and threats to infant mental health present during the COVID-19 pandemic.


Múltiples factores de estrés a nivel de la familia, el hospital y la sociedad han resultado de la pandemia del COVID-19, los cuales han tenido un impacto en el temprano ambiente social de los infantes en el ambiente de la Unidad de Cuidados Intensivos Neonatales (NICU). Este artículo revisa estas situaciones adversas relacionadas con la pandemia, incluyendo las restricciones generales de visita al hospital, el requisito de llevar máscara que interfiere con las expresiones faciales de quien presta el cuidado, la ansiedad de los padres acerca de la transmisión del virus y los reducidos servicios de apoyo. Describimos además adaptaciones al ofrecimiento de servicios de salud mental en NICU para mitigar el aumento del riesgo asociado con las situaciones adversas relacionadas con la pandemia. Estas adaptaciones incluyen la integración de tecnología, la educación y el apoyo del personal, así como el ofrecimiento de material para actividades que promueven la unión afectiva entre progenitor e infante. Se recogió información como parte de la evaluación rutinaria del programa sobre los servicios sicosociales en el caso de una unidad NICU de 50 camas y se describen las preocupaciones de la familia, los obstáculos a la visita, así como la utilización de los servicios de salud mental infantil durante la pandemia. El COVID-19 raramente surgió como el principal asunto que enfrentaban las familias que fueron referidas para intervención de abril a diciembre de 2020. Sin embargo, algunas familias indicaron que las preocupaciones de adquirir una infección y las restricciones de visita presentaron retos significativos a la crianza y/o a la manera de arreglárselas. Se notaron discrepancias significativas entre los patrones de visita de familias con seguro público o con seguro privado. Como respuestas a estas amenazas a la salud mental infantil presentes durante la pandemia del COVID-19, se desarrollaron varias adaptaciones.


Des facteurs de stress multiples aux niveaux de la famille, de l'hôpital et de la société ont résulté de la pandémie du COVID-19 qui impacte l'environnement social précoce des nourrissons dans les Unités Néonatales de Soins Intensifs (UNSI). Cet article passe en revue ces adversités liées à la pandémie, y compris les restrictions pour les visiteurs dans les hôpitaux, les obligations de porter le masque qui interfèrent avec les expressions faciales de la personne prenant soin du bébé, l'anxiété parentale à propos de la transmission du virus et des services de soutien réduits. Nous décrivons des adaptations à la prestation de service de santé mentale dans l'UNSI afin de mitiger le risque accru associé aux adversités liées à la pandémie. Des adaptations ont inclus l'intégration de la technologie, la formation et le soutien aux employés, la livraison de kits d'activités afin d'encourager le lien parent-bébé. Des données ont été recueillies comme faisant partie de l'évaluation de routine de services psychosociaux dans le contexte d'une INSI de 50 lits et décrivent les inquiétudes familiales, les barrières aux visites, l'utilisation de services de santé mentale du nourrisson durant la pandémie. Le COVID-19 a rarement émergé comme étant le problème principal présenté par les familles ayant reçu une intervention d'avril à décembre 2020. Cependant certaines familles ont indiqué que les inquiétudes touchant à l'infection et les restrictions des visites ont posé des défis importants à leur parentage et/ou à leur adaptation. Des différences importantes ont été notées entre les patterns de visites des familles ayant une assurance publique et une assurance privée. Plusieurs adaptations ont été développées pour faire face aux dangers pour la santé mentale infantile présents durant la pandémie de COVID-19.


Subject(s)
COVID-19 , Mental Health Services , Humans , Infant , Infant, Newborn , Infant, Premature , Intensive Care Units, Neonatal , Pandemics , SARS-CoV-2
18.
Hu Li Za Zhi ; 68(6): 73-82, 2021 Dec.
Article in Chinese | MEDLINE | ID: covidwho-1609205

ABSTRACT

BACKGROUND & PROBLEMS: Parent-infant attachment is affected by parent-infant interaction. The limitations on related visitations during the COVID-19 pandemic suspended the opportunity to engage in kangaroo care (skin-to-skin contact) activities. These changes impacted parent-infant attachment in the neonatal intensive care unit. After investigation, the score of premature infant-parent attachment was found to be only 64.6 points during the period in which visitation limitations were in effect. PURPOSE: To enhance maternal-premature infant attachment during the pandemic period by 10% (from an average score of 64.6 to 71.1). RESOLUTION: This project involved nurses playing audio files provided by mothers to their premature infants, and recording a video and taking pictures of the infants during this process. This project used a cloud platform as bidirectional pipelines. Furthermore, emotional support and caring information were provided to the mothers via expressive arts therapy and phone interviews. RESULTS: After the intervention, the premature infant-parent attachment score rose to 74.4 from the pre-intervention score of 64.6. CONCLUSIONS: During pandemic control periods, traditional modes of care aimed at building infant-parent attachment are not applicable. The intervention project used was found to be an effective alternative approach to increasing maternal-premature infant attachment. Breaking the restrictions of time and place, this project applies family-centered care, and may provide a reference for developing software, hardware, and communication equipment for other care units related to newborns.


Subject(s)
COVID-19 , Intensive Care Units, Neonatal , Female , Humans , Infant , Infant, Newborn , Infant, Premature , Mothers , Pandemics , SARS-CoV-2
19.
MMWR Morb Mortal Wkly Rep ; 71(1): 26-30, 2022 Jan 07.
Article in English | MEDLINE | ID: covidwho-1606176

ABSTRACT

COVID-19 vaccines are recommended during pregnancy to prevent severe maternal morbidity and adverse birth outcomes; however, vaccination coverage among pregnant women has been low (1). Concerns among pregnant women regarding vaccine safety are a persistent barrier to vaccine acceptance during pregnancy. Previous studies of maternal COVID-19 vaccination and birth outcomes have been limited by small sample size (2) or lack of an unvaccinated comparison group (3). In this retrospective cohort study of live births from eight Vaccine Safety Datalink (VSD) health care organizations, risks for preterm birth (<37 weeks' gestation) and small-for-gestational-age (SGA) at birth (birthweight <10th percentile for gestational age) after COVID-19 vaccination (receipt of ≥1 COVID-19 vaccine doses) during pregnancy were evaluated. Risks for preterm and SGA at birth among vaccinated and unvaccinated pregnant women were compared, accounting for time-dependent vaccine exposures and propensity to be vaccinated. Single-gestation pregnancies with estimated start or last menstrual period during May 17-October 24, 2020, were eligible for inclusion. Among 46,079 pregnant women with live births and gestational age available, 10,064 (21.8%) received ≥1 COVID-19 vaccine doses during pregnancy and during December 15, 2020-July 22, 2021; nearly all (9,892; 98.3%) were vaccinated during the second or third trimester. COVID-19 vaccination during pregnancy was not associated with preterm birth (adjusted hazard ratio [aHR] = 0.91; 95% CI = 0.82-1.01). Among 40,627 live births with birthweight available, COVID-19 vaccination in pregnancy was not associated with SGA at birth (aHR = 0.95; 95% CI = 0.87-1.03). Results consistently showed no increased risk when stratified by mRNA COVID-19 vaccine dose, or by second or third trimester vaccination, compared with risk among unvaccinated pregnant women. Because of the small number of first-trimester exposures, aHRs for first-trimester vaccination could not be calculated. These data add to the evidence supporting the safety of COVID-19 vaccination during pregnancy. To reduce the risk for severe COVID-19-associated illness, CDC recommends COVID-19 vaccination for women who are pregnant, recently pregnant (including those who are lactating), who are trying to become pregnant now, or who might become pregnant in the future (4).


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Infant, Premature , Infant, Small for Gestational Age , Premature Birth/epidemiology , Adolescent , Adult , Cohort Studies , Female , Humans , Middle Aged , Patient Safety , Pregnancy , Prevalence , Retrospective Studies , Risk Assessment , SARS-CoV-2/immunology , United States/epidemiology , Young Adult
20.
Int J Environ Res Public Health ; 18(24)2021 12 10.
Article in English | MEDLINE | ID: covidwho-1594182

ABSTRACT

The study aim was to explore the effects of multisensory breastmilk interventions on short-term pain of infants during newborn screening. This is a randomized controlled trial. A total of 120 newborns were recruited and assigned by randomization to one of three treatment conditions: Condition 1 = routine care (gentle touch + verbal comfort); Condition 2 = breastmilk odor + routine care; or Condition 3 = breastmilk odor + taste + routine care. Pain was scored with the Neonatal Infant Pain Scale (NIPS). Data were collected from video recordings at 1 min intervals over the 11 phases of heel sticks: phase 1, 5 min before heel stick without stimuli (baseline); phase 2 to phase 6 (during heel stick); and phase 7 to phase 11 (recovery). Generalized estimating equations compared differences in pain scores for newborns over phases among the three conditions. Compared with the routine care, provision of the odor and taste of breastmilk reduce NIPS scores during heel sticks (B = -4.36, SE = 0.45, p < 0.001 [phase6]), and during recovery (B = -3.29, SE = 0.42, p < 0.001 [phase7]). Our findings provide new data, which supports the use of multisensory interventions that include breastmilk odor and taste in combination with gentle touch and verbal comfort to relieve pain in infants undergoing newborn screening.


Subject(s)
Milk, Human , Neonatal Screening , Humans , Infant , Infant, Newborn , Infant, Premature , Pain/diagnosis , Pain/prevention & control , Pain Management
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