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1.
Arch Dis Child ; 2022 Oct 17.
Article in English | MEDLINE | ID: covidwho-2088774
2.
Med J Aust ; 217 Suppl 9: S14-S19, 2022 Nov 06.
Article in English | MEDLINE | ID: covidwho-2056154

ABSTRACT

INTRODUCTION: Pregnant women are at higher risk of severe illness from coronavirus disease 2019 (COVID-19) than non-pregnant women of a similar age. Early in the COVID-19 pandemic, it was clear that evidenced-based guidance was needed, and that it would need to be updated rapidly. The National COVID-19 Clinical Evidence Taskforce provided a resource to guide care for people with COVID-19, including during pregnancy. Care for pregnant and breastfeeding women and their babies was included as a priority when the Taskforce was set up, with a Pregnancy and Perinatal Care Panel convened to guide clinical practice. MAIN RECOMMENDATIONS: As of May 2022, the Taskforce has made seven specific recommendations on care for pregnant women and those who have recently given birth. This includes supporting usual practices for the mode of birth, umbilical cord clamping, skin-to-skin contact, breastfeeding, rooming-in, and using antenatal corticosteroids and magnesium sulfate as clinically indicated. There are 11 recommendations for COVID-19-specific treatments, including conditional recommendations for using remdesivir, tocilizumab and sotrovimab. Finally, there are recommendations not to use several disease-modifying treatments for the treatment of COVID-19, including hydroxychloroquine and ivermectin. The recommendations are continually updated to reflect new evidence, and the most up-to-date guidance is available online (https://covid19evidence.net.au). CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINES: The National COVID-19 Clinical Evidence Taskforce has been a critical component of the infrastructure to support Australian maternity care providers during the COVID-19 pandemic. The Taskforce has shown that a rapid living guidelines approach is feasible and acceptable.


Subject(s)
COVID-19 , Maternal Health Services , Infant , Female , Pregnancy , Humans , Pandemics , Australia/epidemiology , Parturition
3.
Arch Dis Child ; 2022 Sep 28.
Article in English | MEDLINE | ID: covidwho-2053162

ABSTRACT

OBJECTIVE: INGR1D (INvestigating Genetic Risk for type 1 Diabetes) was a type 1 diabetes (T1D) genetic screening study established to identify participants for a primary prevention trial (POInT, Primary Oral Insulin Trial). METHODS: The majority of participants were recruited by research midwives in antenatal clinics from 18 weeks' gestation. Using the NHS Newborn Bloodspot Screening Programme (NBSP) infrastructure, participants enrolled in INGR1D had an extra sample taken from their day 5 bloodspot card sent for T1D genetic screening. Those at an increased risk of T1D were informed of the result, given education about T1D and the opportunity to take part in POInT. RESULTS: Between April 2018 and November 2020, 66% of women approached about INGR1D chose to participate. 15 660 babies were enrolled into INGR1D and 14 731 blood samples were processed. Of the processed samples, 157 (1%) had confirmed positive results, indicating an increased risk of T1D, of whom a third (n=49) enrolled into POInT (20 families were unable to participate in POInT due to COVID-19 lockdown restrictions). CONCLUSION: The use of prospective consent to perform personalised genetic testing on samples obtained through the routine NBSP represents a novel mechanism for clinical genetic research in the UK and provides a model for further population-based genetic studies in the newborn.

4.
BMJ Open ; 12(9): e064731, 2022 09 20.
Article in English | MEDLINE | ID: covidwho-2038320

ABSTRACT

OBJECTIVES: To explore midwives' and maternity support workers' perceptions of the impact of the COVID-19 pandemic on maternity services and understand factors influencing respectful maternity care. DESIGN: A qualitative study. Eleven semistructured interviews were conducted (on Zoom) and thematically analysed. Inductive themes were developed and compared with components of respectful maternity care. SETTING: Maternity services in a diverse region of the United Kingdom. PARTICIPANTS: Midwives and maternity support workers who worked during the first year of the COVID-19 pandemic. RESULTS: The findings offer insights into the experiences and challenges faced by midwives and maternity support workers during the first year of the COVID-19 pandemic in the UK (March 2020-2021). Three core themes were interpreted that impacted respectful maternity care: (1) communication of care, (2) clinical care and (3) support for families. 1. Midwives and maternity support workers felt changing guidance impaired communication of accurate information. However, women attending appointments alone encouraged safeguarding disclosures. 2. Maternity staffing pressures worsened and delayed care provision. The health service's COVID-19 response was thought to have discouraged women's engagement with maternity care. 3. Social support for women was reduced and overstretched staff struggled to fill this role. The continuity of carer model of midwifery facilitated supportive care. COVID-19 restrictions separated families and were considered detrimental to parents' mental health and newborn bonding. Overall, comparison of interview quotes to components of respectful maternity care showed challenges during the early COVID-19 pandemic in upholding each of the 10 rights afforded to women and newborns. CONCLUSIONS: Respectful maternity care was impacted through changes in communication, delivery of clinical care and restrictions on social support for women and their infants in the first year of the COVID-19 pandemic. Future guidance for pandemic scenarios must make careful consideration of women's and newborns' rights to respectful maternity care.


Subject(s)
COVID-19 , Maternal Health Services , Midwifery , Obstetrics , COVID-19/epidemiology , Female , Humans , Infant, Newborn , Pandemics , Pregnancy , Qualitative Research
5.
Pediatrics ; 149, 2022.
Article in English | EMBASE | ID: covidwho-2003032

ABSTRACT

Background: Despite a marked decline in worldwide under-five mortality over the past 30 years, the largest proportion of these deaths remain neonates. In 2018, 4 million (75% of all under-five deaths) infants died worldwide [1]. The neonatal mortality rate in Ethiopia was 28.1 per 100 live births, compared to 17.7 globally and 27.2 in Africa, ranking 23rd for highest neonatal mortality [2]. The Ethiopian Pediatric Society (EPS), entered a virtual partnership with the American Academy of Pediatrics (AAP) in 2020 to provide educational and practical support to clinicians in Ethiopia to perform quality improvement (QI) research. QI training for clinicians at eight Ethiopian sites is modeled on Project ECHO (Extension for Community Healthcare Outcomes) [3]. ECHO improves capacity for specialists to deliver care to underserved communities via collaboration with local clinicians using video teleconferencing, which has been a particularly advantageous tool to continue global health work during the COVID-19 pandemic. The goal of this project is to support local Ethiopian providers in designing, implementing, and assessing a QI intervention. Methods: We adapt the Project ECHO model to have U.S. neonatology faculty-fellow teams mentor clinicians from 8 hospitals in Ethiopia. Using video conferencing and regular contact through mobile devices, teams work to identify gaps in care, create SMART aim statements, identify key stakeholders and barriers to change, and implement interventions. Interventions are measured with a phone application, Liveborn, which allows instant transmission of data internationally. Sites provide monthly progress updates to the EPS. AAP/EPS leadership, U.S.-based faculty-fellow teams, and QI team leaders meet monthly via video conference for didactic sessions on QI methodology followed by teams presenting their progress, which promotes discussion and collaboration between the sites, AAP/EPS leadership, and U.S. mentorship teams to address any barriers. Results: Teams identified compliance with delayed cord clamping (DCC) and skin-to-skin (STS) after delivery as a gap by independently collecting local data. QI teams are currently still implementing interventions and measuring improvement. Teams have identified several barriers, the most common cited being stakeholder buy-in and logistic challenges in implementation. During monthly meetings, teams continually discuss and brainstorm ways to address barriers overall and among individual sites. Conclusion: Via the ECHO model, the AAP and EPS are supporting Ethiopian QI teams in designing and implementing QI interventions despite the limitations imposed by the COVID-19 pandemic. Challenges to this mentorship process include communication barriers (language, internet network) and perception of lack of need by Ethiopian clinicians for U.S. mentorship. Using the ECHO model, all teams have defined SMART aims, begun to implement interventions, and are now collecting compliance data.

6.
Akusherstvo i Ginekologiya (Russian Federation) ; 2022(5):118-127, 2022.
Article in Russian | EMBASE | ID: covidwho-1988723

ABSTRACT

The article presents the results of the surveillance of severe maternal morbidity (SMM) according to SMM surveillance regulations in the Russian Federation (RF). The study analyzed the SMM Register of the Vertically Integrated Medical Information System of Obstetrics and Gynecology and Neonatology (VIMIS AKU&NEO) and the results of near-miss audit. The analysis included life-threatening maternal conditions without fatal outcome identified according to categories of organ dysfunction using the WHO diagnostic criteria (2011). The study aimed to identify strategies to reduce and prevent maternal mortality (MM) in Saint Petersburg. The authors analyzed the types of SMM registered in level II (51.0%) and level III (49.0%) maternal care providers (MCP) of Saint Petersburg. They also presented characteristics of near-miss cases, of which 12.5% and 83.3% occurred in level II and level III MCPs, respectively. Integral indicators of medical care quality in near-miss groups included near-miss rate, life-threatening condition rate, survival rate index, and mortality rate index. Obstetric pathology, blood pathology, and respiratory pathology were the leading causes of SMM in Saint Petersburg in 2021, which is comparable with the data of SMM registered in the Russian Federation in general. There were no cases of MM in the obstetric pathology group, which was the most frequently registered category of SMM (39.4% of the total number of SMM), including severe pre-eclampsia and eclampsia (83.1% of the group) and uterine rupture (9.6% of the group). The absence of MM in this category of SMM is associated with the implementation of effective and quality medical care in patients at high risk for obstetric and perinatal complications in Saint Petersburg in 2021. Blood pathology was the second most frequently registered category of SMM (36.8% of all SMM, 95.8% of the group);one case of MM was registered in a Level III MCP and one case outside the MCP before ambulance arrival. Both cases were associated with massive blood loss (more than 1000 ml). In 2021, during a pandemic of a novel coronavirus infection (COVID-19) in St. Petersburg, 41 cases of SMM associated with respiratory pathology (9.1% of total SMM) were reported. Of them 39 were identified as near-miss cases (respiratory dysfunction), which accounted for 54, 2% of the total number of near-miss cases with 20 deaths in level III MCPs. These deaths were due to severe or extremely severe bilateral viral or viral bacterial pneumonia complicated by acute respiratory distress syndrome or pulmonary embolism due to COVID-19 (O98. 5, U07.1). The main strategy to prevent and reduce the incidence of near-miss cases and MM based on improving the modern integral model of internal control of the quality of medical care in maternal care providers, near-miss audit, and the introduction into practice of both medical and organizational methodological, including telecommunications and other technologies aimed at improving professional competence. Conclusion: SMM surveillance and near-miss audit allows for a detailed assessment of the nature and quality of medical care to improve pregnancy outcomes.

7.
BMC Pregnancy Childbirth ; 22(1): 119, 2022 Feb 11.
Article in English | MEDLINE | ID: covidwho-1974120

ABSTRACT

BACKGROUND: The provision of care to pregnant persons and neonates must continue through pandemics. To maintain quality of care, while minimizing physical contact during the Severe Acute Respiratory Syndrome-related Coronavirus-2 (SARS-CoV2) pandemic, hospitals and international organizations issued recommendations on maternity and neonatal care delivery and restructuring of clinical and academic services. Early in the pandemic, recommendations relied on expert opinion, and offered a one-size-fits-all set of guidelines. Our aim was to examine these recommendations and provide the rationale and context to guide clinicians, administrators, educators, and researchers, on how to adapt maternity and neonatal services during the pandemic, regardless of jurisdiction. METHOD: Our initial database search used Medical subject headings and free-text search terms related to coronavirus infections, pregnancy and neonatology, and summarized relevant recommendations from international society guidelines. Subsequent targeted searches to December 30, 2020, included relevant publications in general medical and obstetric journals, and updated society recommendations. RESULTS: We identified 846 titles and abstracts, of which 105 English-language publications fulfilled eligibility criteria and were included in our study. A multidisciplinary team representing clinicians from various disciplines, academics, administrators and training program directors critically appraised the literature to collate recommendations by multiple jurisdictions, including a quaternary care Canadian hospital, to provide context and rationale for viable options. INTERPRETATION: There are different schools of thought regarding effective practices in obstetric and neonatal services. Our critical review presents the rationale to effectively modify services, based on the phase of the pandemic, the prevalence of infection in the population, and resource availability.


Subject(s)
COVID-19/prevention & control , Communicable Disease Control/organization & administration , Delivery of Health Care/organization & administration , Maternal-Child Health Services/organization & administration , Perinatal Care , Practice Guidelines as Topic , Pregnancy Complications, Infectious/prevention & control , Academic Medical Centers , COVID-19/therapy , Canada , Female , Humans , Infant , Infant, Newborn , Inpatients , Organizational Policy , Outpatients , Pregnancy , Pregnancy Complications, Infectious/therapy , SARS-CoV-2
8.
Am J Obstet Gynecol MFM ; 4(6): 100697, 2022 Jul 22.
Article in English | MEDLINE | ID: covidwho-1956058

ABSTRACT

BACKGROUND: Pregnant individuals are vulnerable to COVID-19-related acute respiratory distress syndrome. There is a lack of high-quality evidence on whether elective delivery or expectant management leads to better maternal and neonatal outcomes. OBJECTIVE: This study aimed to determine whether elective delivery or expectant management are associated with higher quality-adjusted life expectancy for pregnant individuals with COVID-19-related acute respiratory distress syndrome and their neonates. STUDY DESIGN: We performed a clinical decision analysis using a patient-level model in which we simulatedpregnant individuals and their unborn children. We used a patient-level model with parallel open-cohort structure, daily cycle length, continuous discounting, lifetime horizon, sensitivity analyses for key parameter values, and 1000 iterations for quantification of uncertainty. We simulated pregnant individuals at 32 weeks of gestation, invasively ventilated because of COVID-19-related acute respiratory distress syndrome. In the elective delivery strategy, pregnant individuals received immediate cesarean delivery. In the expectant management strategy, pregnancies continued until spontaneous labor or obstetrical decision to deliver. For both pregnant individuals and neonates, model outputs were hospital or perinatal survival, life expectancy, and quality-adjusted life expectancy denominated in years, summarized by the mean and 95% credible interval. Maternal utilities incorporated neonatal outcomes in accordance with best practices in perinatal decision analysis. RESULTS: Model outputs for pregnant individuals were similar when comparing elective delivery at 32 weeks' gestation with expectant management, including hospital survival (87.1% vs 87.4%), life-years (difference, -0.1; 95% credible interval, -1.4 to 1.1), and quality-adjusted life expectancy denominated in years (difference, -0.1; 95% credible interval, -1.3 to 1.1). For neonates, elective delivery at 32 weeks' gestation was estimated to lead to a higher perinatal survival (98.4% vs 93.2%; difference, 5.2%; 95% credible interval, 3.5-7), similar life-years (difference, 0.9; 95% credible interval, -0.9 to 2.8), and higher quality-adjusted life expectancy denominated in years (difference, 1.3; 95% credible interval, 0.4-2.2). For pregnant individuals, elective delivery was not superior to expectant management across a range of scenarios between 28 and 34 weeks of gestation. Elective delivery in cases where intrauterine death or maternal mortality were more likely resulted in higher neonatal quality-adjusted life expectancy, as did elective delivery at 30 weeks' gestation (difference, 1.1 years; 95% credible interval, 0.1 - 2.1) despite higher long-term complications (4.3% vs 0.5%; difference, 3.7%; 95% credible interval, 2.4-5.1), and in cases where intrauterine death or maternal acute respiratory distress syndrome mortality were more likely. CONCLUSION: The decision to pursue elective delivery vs expectant management in pregnant individuals with COVID-19-related acute respiratory distress syndrome should be guided by gestational age, risk of intrauterine death, and maternal acute respiratory distress syndrome severity. For the pregnant individual, elective delivery is comparable but not superior to expectant management for gestational ages from 28 to 34 weeks. For neonates, elective delivery was superior if gestational age was ≥30 weeks and if the rate of intrauterine death or maternal mortality risk were high. We recommend basing the decision for elective delivery vs expectant management in a pregnant individual with COVID-19-related acute respiratory distress syndrome on gestational age and likelihood of intrauterine or maternal death.

9.
BMJ Paediatr Open ; 6(1)2022 07.
Article in English | MEDLINE | ID: covidwho-1950204

ABSTRACT

INTRODUCTION: Improved parental experience is related to improved mental and physical health outcomes for the infant. The COVID-19 pandemic abruptly impacted on healthcare delivery and services need information to shape how to manage the disruption and recovery. METHODS: Our aim was to develop a systematic process to capture parents' experience of their neonatal surgical healthcare journey during the pandemic. We identified relevant stakeholders and using semistructured interviews, we explored three key themes.(1) How to recruit and collect data from representative parents?(2) What questions should be asked?(3) How to disseminate results for service development? RESULTS: Responses indicated the need to involve 'difficult to access groups' (eg, first language not English, high social deprivation, low health literacy), defined the range of family and patient characteristics variables to be considered for representative responses (eg, antenatal diagnosis, disease complexity, number of siblings, single parent, parental health). The proposed questions were grouped into five main topics: information preadmission; in-patient experience; support during admission; the effect of COVID-19; discharge and posthospital experience. Recommendations for dissemination included local, regional and national fora as well as the need to feedback to participants about the changes made.Based on the analysis, we developed a semistructured interview which underwent cognitive testing, prepilot and pilot phase testing. DISCUSSION: This protocol is grounded in the views of relevant stakeholders to ensure it captures relevant information in a pragmatic but methodologically sound way. It will next be used to assess parental experience in a large neonatal surgical unit. We hope that the protocol could be adapted and used by other groups.


Subject(s)
COVID-19 , Delivery of Health Care , Female , Humans , Infant , Infant, Newborn , Pandemics , Parents/psychology , Pregnancy , Qualitative Research
10.
J Paediatr Child Health ; 58(10): 1747-1752, 2022 10.
Article in English | MEDLINE | ID: covidwho-1916256

ABSTRACT

AIM: During the first wave of coronavirus disease 2019 (COVID-19), visiting guidelines in neonatal units changed to maintain the health and safety of staff, neonates, and families. In the neonatal intensive care unit/special care nursery (NICU/SCN), restrictions were placed on parental contact and extended family excluded. Our team was interested in evaluating the effect of these restrictions on parental stress and discharge confidence. METHODS: A prospective descriptive study utilising survey methodology was undertaken. The survey was developed and previously used by the NICU research group to evaluate parental knowledge and understanding, parental role, communication, and parental stress (admission/discharge). We have also included a section regarding COVID19 visiting restrictions (ETH.2020.LRE.00124). The survey used a five-level Likert scale. Statistical analysis was completed using SPSS version 21. RESULTS: Notably, 33 surveys were returned. Results showed visiting restrictions reduced social contact between partners 26/33 (84%), with their other children 14/16 (87.5%) and extended family 28/33 (84.8%). Parents indicated that they had high levels of confidence in understanding their babies' medical needs (78-93%) and gaining hands-on experience caring for their baby (87-100%). However, 11/33 (33%) of parents reported concerns with discharge processes and gaining consistent information as challenges during their baby's admission. Notably, 17/33 (51.5) stated their NICU/SCN experience had been very to extremely stressful. Parents openly described how the restrictions had affected their mental/emotional health identifying the need to treat parents as one unit, and a gap in the psychological support available for families. CONCLUSION: Support services and consistency of communication with NICU/SCN families need to be enhanced and prioritised during periods of restrictions, especially peri-discharge.


Subject(s)
COVID-19 , Intensive Care Units, Neonatal , Child , Communication , Humans , Infant , Infant, Newborn , Parents/psychology , Patient Discharge
11.
Archives of Disease in Childhood. Fetal and Neonatal Edition ; 107(4):343, 2022.
Article in English | ProQuest Central | ID: covidwho-1901948

ABSTRACT

The observation is similar to that of Ju Lee Oei and colleagues, who report an individual patient data meta-analysis of 3 randomised clinical trials comparing the effects on a composite of death or disability of initial resuscitation with 30% or 60% oxygen for preterm infants born <32 weeks gestation. See pages F437 and F386 Surfactant in late preterm and term infants Viraraghavan Vadakkencherry Ramaswamy and colleagues performed a systematic review and meta-analysis of studies of surfactant therapy for term and late preterm infants with respiratory distress syndrome. Most of the information in these more mature infants was derived from observational studies so there were issues with the level of certainty of the evidence showing that surfactant therapy decreased mortality, air leak, persistent pulmonary hypertension of the newborn, duration of ventilation and of hospital stay.

12.
Arch Dis Child ; 107(7): 644-649, 2022 07.
Article in English | MEDLINE | ID: covidwho-1901944

ABSTRACT

The World Health Organization (WHO) has a mandate to promote maternal and child health and welfare through support to governments in the form of technical assistance, standards, epidemiological and statistical services, promoting teaching and training of healthcare professionals and providing direct aid in emergencies. The Strategic and Technical Advisory Group of Experts (STAGE) for maternal, newborn, child and adolescent health and nutrition (MNCAHN) was established in 2020 to advise the Director-General of WHO on issues relating to MNCAHN. STAGE comprises individuals from multiple low-income and middle-income and high-income countries, has representatives from many professional disciplines and with diverse experience and interests.Progress in MNCAHN requires improvements in quality of services, equity of access and the evolution of services as technical guidance, community needs and epidemiology changes. Knowledge translation of WHO guidance and other guidelines is an important part of this. Countries need effective and responsive structures for adaptation and implementation of evidence-based interventions, strategies to improve guideline uptake, education and training and mechanisms to monitor quality and safety. This paper summarises STAGE's recommendations on how to improve knowledge translation in MNCAHN. They include support for national and regional technical advisory groups and subnational committees that coordinate maternal and child health; support for national plans for MNCAHN and their implementation and monitoring; the production of a small number of consolidated MNCAHN guidelines to promote integrated and holistic care; education and quality improvement strategies to support guidelines uptake; monitoring of gaps in knowledge translation and operational research in MNCAHN.


Subject(s)
Adolescent Health , Maternal Health Services , Adolescent , Child , Family , Female , Humans , Infant, Newborn , Nutritional Status , Pregnancy , Translational Science, Biomedical , World Health Organization
13.
Arch Dis Child Fetal Neonatal Ed ; 107(4): 344-345, 2022 07.
Article in English | MEDLINE | ID: covidwho-1901943
14.
Akusherstvo i Ginekologiya (Russian Federation) ; 2022(3):5-11, 2022.
Article in Russian | EMBASE | ID: covidwho-1870194

ABSTRACT

The paper shows the changes that have determined the features of modern obstetrics. A sharp decline in birth rates and the elements of depopulation in the country have created new conditions for reforming healthcare and modern obstetrics. Each pregnancy and each child have acquired a special value. In the country, prenatal diagnosis has been introduced and neonatology has evolved. The obstetric strategy has become more active;surgical delivery has increased significantly. Caesarean sections are performed 8—10 times more often. The intensive care and rehabilitation of premature and sick newborns are being actively improved. Maternal and infant mortalities have decreased by 8—10 and 5—6 times, respectively. However, there have been new problems: an increase in the number of bleedings due to placenta previa and placenta increta in pregnant women who have undergone a caesarean section. Antibiotics have become less effective;the number of postpartum infectious diseases has increased. More and more babies are being born premature. The role of extragenital diseases in obstetric pathology has increased;this is especially clearly manifested during the coronavirus pandemic. Treatment for infertility has been improved;assisted reproductive technologies, including in vitro fertilization, are being actively developed. In recent years, much has been done to improve and develop the foundation of obstetrics;93 perinatal centers are functioning, all obstetric facilities have been provided with modern diagnostic and medical equipment. Conclusion: Modern obstetrics has a perinatal direction. Obstetricians are actively involved in solving the demographic problems facing the country. Modern obstetric strategies can reduce maternal and infant morbidity and mortality.

15.
BMJ Open ; 12(4): e057073, 2022 04 26.
Article in English | MEDLINE | ID: covidwho-1854347

ABSTRACT

INTRODUCTION: Neonatal hypoxic-ischaemic encephalopathy (HIE) is an important illness associated with death or cerebral palsy. This study aims to assess the safety and tolerability of the allogenic human multilineage-differentiating stress-enduring cell (Muse cell)-based product (CL2020) cells in newborns with HIE. This is the first clinical trial of CL2020 cells in neonates. METHODS AND ANALYSIS: This is a single-centre, open-label, dose-escalation study enrolling up to 12 patients. Neonates with HIE who receive a course of therapeutic hypothermia therapy, which cools to a body temperature of 33°C-34°C for 72 hours, will be included in this study. A single intravenous injection of CL2020 cells will be administered between 5 and 14 days of age. Subjects in the low-dose and high-dose cohorts will receive 1.5 and 15 million cells per dose, respectively. The primary outcome is the occurrence of any adverse events within 12 weeks after administration. The main secondary outcome is the Bayley Scales of Infant and Toddler Development Third Edition score and the developmental quotient per the Kyoto Scale of Psychological Development 2001 at 78 weeks. ETHICS AND DISSEMINATION: This study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. The Nagoya University Hospital Institutional Review Board (No. 312005) approved this study on 13 November 2019. The results of this study will be published in peer-reviewed journal and reported in international conferences. TRIAL REGISTRATION NUMBERS: NCT04261335, jRCT2043190112.


Subject(s)
Hypothermia, Induced , Hypoxia-Ischemia, Brain , Body Temperature , Humans , Hypothermia, Induced/methods , Hypoxia-Ischemia, Brain/therapy , Infant , Infant, Newborn , Protective Devices , Research
16.
BMJ Open ; 12(5), 2022.
Article in English | ProQuest Central | ID: covidwho-1848695

ABSTRACT

IntroductionDocosahexaenoic acid (DHA), an omega-3 fatty acid, is important for brain development with possible implications in neurodevelopmental outcomes. In the two-arm, randomised, double-blind, placebo-controlled Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia in Very Preterm Infants trial, very preterm infants (<29 weeks’ gestation) were supplemented in high doses of DHA or placebo until they reached 36 weeks’ postmenstrual age. We propose a long-term neurodevelopmental follow-up of these children. This protocol details the follow-up at 5 years of age, which aims to (1) confirm our long-term recruitment capacity and (2) determine the spectrum of neurodevelopmental outcomes at preschool age following neonatal DHA supplementation.Methods and analysisThis long-term follow-up involves children (n=194) born to mothers (n=170) randomised to DHA (n=85) or placebo (n=85) from the five sites in Quebec when they will be 5 years’ corrected age. The primary outcome measure is related to the long-term recruitment capacity, which we determined as successful if 75% (±10%, 95% CI) of the eligible children consent to the 5-year follow-up study. Interviews with mothers will be conducted to assess various aspects of neurodevelopment at preschool age (executive functions, behavioural problems, global development and health-related quality of life), evaluated with standardised neurodevelopmental questionnaires. In addition, a semistructured interview conducted in a subset of the mothers will be used to determine their acceptability and identify barriers and enablers to their eventual participation to the next phase of the trial. This follow-up study will require approximately 22 months to be completed.Ethics and disseminationThis study was approved by the CHU de Québec-Université Laval Research Ethics Board (MP-20-2022-5926). Mothers will provide informed consent before participating in this study. Findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNCT02371460.

17.
Arch Dis Child Fetal Neonatal Ed ; 2022 May 11.
Article in English | MEDLINE | ID: covidwho-1840562

ABSTRACT

OBJECTIVE: To assess the impact of public health measures taken during the COVID-19 pandemic on perinatal health indicators. DESIGN: Interrupted time series analysis comparing periods of the pandemic with the previous 5 years. SETTING: Yorkshire and the Humber region, England (2015-2020). MAIN OUTCOME MEASURES: Relative risk (RR) of stillbirth, extreme preterm (EPT, <27 weeks' gestational age) delivery, hypoxic ischaemic encephalopathy (HIE) and meconium aspiration syndrome (MAS), antenatal transfer for threatened EPT delivery and postnatal transfer for EPT birth, HIE or MAS. RESULTS: Stillbirths fell from 3.7/1000 deliveries prepandemic to 2.9/1000 afterwards; EPT births decreased from 2.5/1000 to 1.8/1000 live births. Following adjustment, during the first lockdown there were decreased antenatal transfers (RR 0.74, 95% CI 0.57 to 0.94) with non-statistically significant increased stillbirth (RR 1.08, 95% CI 0.78 to 1.51) and decreased EPT admissions (RR 0.88, 95% CI 0.60 to 1.29). Over the entire pandemic period, antenatal transfer (RR 0.64, 95% CI 0.55 to 0.76) and EPT birth (RR 0.73, 95% CI 0.56 to 0.94) decreased; stillbirths showed non-statistically significant increases overall (RR 1.21, 95% CI 0.98 to 1.49) but with increasing trend through the pandemic (RR 1.11, 95% CI 1.00 to 1.22). No changes were seen for HIE, MAS, postnatal transfers or in subgroup analyses by ethnicity. CONCLUSIONS: Lower rates of antenatal transfer and extreme preterm birth were identified, alongside an apparent increase in stillbirth over time. The findings provide evidence that effects on perinatal activity related to the pandemic changed over time.

18.
Front Pediatr ; 10: 787947, 2022.
Article in English | MEDLINE | ID: covidwho-1809481

ABSTRACT

Objective: The COVID-19 lockdown extended premature rupture of membranes (PROM) expectant time among nulliparas and increased the risk of term neonatal complications. This study investigated the impact of term nulliparas with PROM delays at home on neonatal outcomes during the COVID-19 lockdown period, considering the clinical diagnostic application of maternal C-reactive protein (CRP). Methods: This study collected 505 term nulliparous women who underwent PROM at home from five provinces in a non-designated hospital of China in 2020. We analyzed PROM maternal information at home and neonatal complications in the COVID-19 regional lockdown and compared related information in the national lockdown. Poisson regression models estimated the correlation of PROM management at home, maternal CRP, and neonatal morbidity. We constructed two diagnostic models: the CRP univariate model, and an assessed cut-off value of CRP in the combined model (CRP with PROM waiting time at home). Results: In the regional lockdown, PROM latency at home and the severity of neonatal complications were extended and increased lower than in the nationwide lockdown, but term neonatal morbidity was not reduced in the COVID-19 localized lockdown. Prolonged waiting time at home (≥8.17 h) was associated with increasing maternal CRP values and neonatal morbidity (adjusted risk ratio 2.53, 95% CI, 1.43 to 4.50, p for trend <0.001) in the regional lockdown period. In the combined model, CRP ≥7 mg/L with PROM latency ≥8.17 h at home showed higher diagnostic sensitivity and AUC than only CRP for initial assessing the risk of adverse neonatal complications in COVID-19 regional lockdowns (AUC, 0.714 vs. 0.534; sensitivity, 0.631 vs. 0.156). Conclusion: The impact of the acute COVID-19 national blockade on the PROM newborns' health could continue to the COVID-19 easing period. Maternal CRP reference interval (≥7 mg/L) would effectively assess the risk of term neonatal morbidity when nulliparas underwent prolonged PROM expectant at home (≥8.17 h) during the second COVID-19 lockdown.

19.
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
20.
BMJ Open ; 12(4): e056753, 2022 04 08.
Article in English | MEDLINE | ID: covidwho-1784822

ABSTRACT

OBJECTIVES: Develop and validate a WHO Standards-based online questionnaire to measure the quality of maternal and newborn care (QMNC) around the time of childbirth from the health workers' perspective. DESIGN: Mixed-methods study. SETTING: Six countries of the WHO European Region. PARTICIPANTS AND METHODS: The questionnaire is based on lessons learnt in previous studies, and was developed in three sequential phases: (1) WHO Quality Measures were prioritised and content, construct and face validity were assessed through a Delphi involving a multidisciplinary board of experts from 11 countries of the WHO European Region; (2) translation/back translation of the English version was conducted following The Professional Society for Health Economics and Outcomes Research guidelines; (3) internal consistency, intrarater reliability and acceptability were assessed among 600 health workers in six countries. RESULTS: The questionnaire included 40 items based on WHO Standards Quality Measures, equally divided into four domains: provision of care, experience of care, availability of human and physical resources, organisational changes due to COVID-19; and its organised in six sections. It was translated/back translated in 12 languages: Bosnian, Croatian, French, German, Italian, Norwegian, Portuguese, Romanian, Russian, Slovenian, Spanish and Swedish. The Cronbach's alpha values were ≥0.70 for each questionnaire section where questions were hypothesised to be interrelated, indicating good internal consistence. Cohen K or Gwet's AC1 values were ≥0.60, suggesting good intrarater reliability, except for one question. Acceptability was good with only 1.70% of health workers requesting minimal changes in question wording. CONCLUSIONS: Findings suggest that the questionnaire has good content, construct, face validity, internal consistency, intrarater reliability and acceptability in six countries of the WHO European Region. Future studies may further explore the questionnaire's use in other countries, and how to translate evidence generated by this tool into policies to improve the QMNC. TRAIL REGISTRATION NUMBER: NCT04847336.


Subject(s)
COVID-19 , Female , Humans , Infant, Newborn , Pregnancy , Psychometrics , Quality of Health Care , Reproducibility of Results , Surveys and Questionnaires , World Health Organization
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