Impact of Perinatal Exposure to SARS-CoV-2 Infection on Early Health Outcomes among Infants Born from 2020 to 2021 in British Columbia, Canada.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has impacted healthcare services and outcomes. We aimed to investigate healthcare resource utilization and early health outcomes of infants born to mothers with perinatal SARS-CoV-2 infection. Methods: The study included all infants born alive between February 1, 2020, and April 30, 2021, in British Columbia. We used linked provincial population-based databases including data on COVID-19 testing, birth, and health information for up to one year from birth. Perinatal COVID-19 exposure for infants was defined being born to mothers with a positive test for SARS-CoV-2 infection during pregnancy or at delivery. Cases of COVID-19-exposed infants were matched with up to four non-exposed infants by birth month, sex, birthplace, and gestational age in weeks. Outcomes included hospitalizations, emergency department visits, and in-/outpatient diagnoses. Outcomes were compared between groups using conditional logistic regression and linear mixed effects models including effect modification by maternal residence. Results: Among 52,711 live births, 484 infants had perinatal exposure to SARS-CoV-2, an incidence rate of 9.18 per 1000 live births. Exposed infants (54.6% male) had a mean gestational age of 38.5 weeks, and 99% were born in hospital. Proportions of infants requiring at least one hospitalization (8.1% vs. 5.1%) and at least one emergency department visit (16.9% vs. 12.9%) were higher among the exposed vs. unexposed infants, respectively. Among infants from the urban area, those with exposure were more likely to have respiratory infectious diseases (odds ratio: 1.74; 95% confidence intervals: 1.07, 2.84), compared with those without exposure. Interpretation. In our cohort, infants born to mothers with SARS-CoV-2 infection have increased healthcare demands in their early infancy, which warrants further investigation.

Experiences of Mothers of Preterm Infants in the Neonatal Intensive Care Unit During the COVID-19 Pandemic.

BACKGROUND: The neonatal intensive care unit (NICU) stay following the birth of a preterm infant can be stressful and traumatic for families. During the COVID-19 pandemic, the NICU environment changed precipitously as infection control and visitor restriction measures were implemented. PURPOSE: Our study aimed to examine the impact of the pandemic policies on the experiences of mothers of preterm infants during their stay in the NICU. METHODS: Semistructured interviews were conducted with mothers of preterm infants hospitalized in a Canadian tertiary-level NICU. Informed by interpretive description methodology, interview content was transcribed and analyzed using a thematic analysis approach. The identified themes were validated, clarified, or refined using investigator triangulation. RESULTS: Nine English-speaking mothers, aged 28 to 40 years, were interviewed. Four themes emerged from the analysis of their experiences: (1) disrupted family dynamic, support, and bonding; (2) physical and emotional isolation; (3) negative psychological impact compounded by added concerns, maternal role change, and survival mode mentality; and (4) positive aspects of the pandemic management measures. IMPLICATIONS FOR PRACTICE: During the pandemic, the way that care was provided in the NICU changed. This study helps to explore how neonatal clinicians can foster individual and organizational resilience to keep patients and families at the center of care, even when the healthcare system is under intense stress. IMPLICATIONS FOR RESEARCH: : Our results show that these changes heightened mothers' distress, but also had a modest positive impact. Further research about long-term consequences of pandemic policies on the mother and preterm infant after NICU discharge is warranted.

Factors Associated with Umbilical Venous Catheter Malposition in Newborns: A Tertiary Center Experience.

OBJECTIVE: Umbilical venous catheters (UVC) are widely used in neonatal intensive care (NICU). Noncentral catheter position is known to be associated with multiple adverse complications; however, risk factors for catheter malposition are unclear. This work aimed to identify clinical risk factors and complications associated with UVC malposition in neonates admitted in an NICU. STUDY DESIGN: A retrospective chart review was performed of inborn babies admitted to BC Women's Hospital NICU with UVC inserted in their first 7 days between July 2016 and June 2018. Infant and maternal demographic, radiograph, UVC-related data, and complications were reviewed. RESULTS: A total of 257 infants had UVC placed; 158 (61%) and 99 (39%) were in central and noncentral positions after initial placement, respectively. Of initially central-placed UVCs, a further 35 (22%) were pulled back or migrated to malposition on follow-up X-ray. Multivariable logistic regression analysis revealed the use of larger UV (5 Fr) catheter (odds ratio [OR]: 2.5, 95% confidence interval [CI]: 1.1-5.6, p = 0.026) and escalation of respiratory support mode (OR: 1.7, 95% CI: 1.0-2.8, p = 0.049) as significant predictors of catheter malposition. CONCLUSION: Noncentral UVC position as well as migration were common after initial placement in this cohort. The use of larger size UV catheters and increasingly invasive respiratory support were risk factors associated with higher incidence of UVC malposition. Ongoing surveillance of UVC position is thus recommended. KEY POINTS: · More than one-third of UV catheters were not in central position after the initial placement.. · Large size UV catheters and increasingly invasive respiratory support were risk factors for UV malposition.. · High incidence of UVC migration was found after initial central placement, warranting surveillance..

Coached, Coordinated, Enhanced Neonatal Transition (CCENT): protocol for a multicentre pragmatic randomised controlled trial of transition-to-home support for parents of high-risk infants.

INTRODUCTION: Having an infant admitted to the neonatal intensive care unit (NICU) is associated with increased parental stress, anxiety and depression. Enhanced support for parents may decrease parental stress and improve subsequent parent and child outcomes. The Coached, Coordinated, Enhanced Neonatal Transition (CCENT) programme is a novel bundled intervention of psychosocial support delivered by a nurse navigator that includes Acceptance and Commitment Therapy-based coaching, care coordination and anticipatory education for parents of high-risk infants in the NICU through the first year at home. The primary objective is to evaluate the impact of the intervention on parent stress at 12 months. METHODS AND ANALYSIS: This is a multicentre pragmatic randomised controlled superiority trial with 1:1 allocation to the CCENT model versus control (standard neonatal follow-up). Parents of high-risk infants (n=236) will be recruited from seven NICUs across three Canadian provinces. Intervention participants are assigned a nurse navigator who will provide the intervention for 12 months. Outcomes are measured at baseline, 6 weeks, 4, 12 and 18 months. The primary outcome measure is the total score of the Parenting Stress Index Fourth Edition Short Form at 12 months. Secondary outcomes include parental mental health, empowerment and health-related quality of life for calculation of quality-adjusted life years (QALYs). A cost-effectiveness analysis will examine the incremental cost of CCENT versus usual care per QALY gained. Qualitative interviews will explore parent and healthcare provider experiences with the intervention. ETHICS AND DISSEMINATION: Research ethics approval was obtained from Clinical Trials Ontario, Children's Hospital of Eastern Ontario Research Ethics Board (REB), The Hospital for Sick Children REB, UBC Children's and Women's REB and McGill University Health Centre REB. Results will be shared with Canadian level III NICUs, neonatal follow-up programmes and academic forums. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03350243).

Outcomes of Neonates With Complex Medical Needs.

BACKGROUND: Children with complex medical needs (CMN) are high healthcare resource utilizers, have varying underlying diagnoses, and experience repeated hospitalizations. Outcomes on neonatal intensive care (NICU) patients with CMN are unknown. PURPOSE: The primary aim is to describe the clinical profile, resource use, prevalence, and both in-hospital and postdischarge outcomes of neonates with CMN. The secondary aim is to assess the feasibility of sustaining the use of the neonatal complex care team (NCCT). METHODS: A retrospective cohort study was conducted after implementing a new model of care for neonates with CMN in the NICU. All neonates born between January 2013 and December 2016 and who met the criteria for CMN and were cared for by the NCCT were included. RESULTS: One hundred forty-seven neonates with a mean (standard deviation) gestational age of 34 (5) weeks were included. The major underlying diagnoses were genetic/chromosomal abnormalities (48%), extreme prematurity (26%), neurological abnormality (12%), and congenital anomalies (11%). Interventions received included mechanical ventilation (69%), parenteral nutrition (68%), and technology dependency at discharge (91%). Mortality was 3% before discharge and 17% after discharge. Postdischarge hospital attendances included emergency department visits (44%) and inpatient admissions (58%), which involved pediatric intensive care unit admissions (26%). IMPLICATIONS FOR PRACTICE: Neonates with CMN have multiple comorbidities, high resource needs, significant postdischarge mortality, and rehospitalization rates. These cohorts of NICU patients can be identified early during their NICU course and serve as targets for implementing innovative care models to meet their unique needs. IMPLICATIONS FOR RESEARCH: Future studies should explore the feasibility of implementing innovative care models and their potential impact on patient outcomes and cost-effectiveness.

Effect of Early Parenteral Nutrition Discontinuation on Time to Regain Birth Weight in Very Low Birth Weight Infants: A Randomized Controlled Trial.

BACKGROUND: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants. METHODS: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight. RESULTS: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008). CONCLUSIONS: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g.

2% chlorhexidine-70% isopropyl alcohol versus 10% povidone-iodine for insertion site cleaning before central line insertion in preterm infants: a randomised trial.

OBJECTIVE: To determine whether 2% chlorhexidine gluconate-70% isopropyl alcohol (CHX-IA) is superior to 10% aqueous povidone-iodine (PI) in preventing catheter-related blood stream infection (CR-BSI) when used to clean insertion sites before placing central venous catheters (CVCs) in preterm infants. DESIGN: Randomised controlled trial. SETTING: Two neonatal intensive care units (NICUs). PATIENTS: Infants <31 weeks' gestation who had a CVC inserted. INTERVENTIONS: Insertion site was cleaned with CHX-IA or PI. Caregivers were not masked to group assignment. MAIN OUTCOME MEASURES: Primary outcome was CR-BSI determined by one microbiologist who was masked to group assignment. Secondary outcomes included skin reactions to study solution and thyroid dysfunction. RESULTS: We enrolled 304 infants (CHX-IA 148 vs PI 156) in whom 815 CVCs (CHX-IA 384 vs PI 431) were inserted and remained in situ for 3078 (CHX-IA 1465 vs PI 1613) days. We found no differences between the groups in the proportion of infants with CR-BSI (CHX-IA 7% vs PI 5%, p=0.631), the proportion of CVCs complicated by CR-BSI or the rate of CR-BSI per 1000 catheter days. Skin reaction rates were low (<1% CVC insertion episodes) and not different between the groups. More infants in the PI group had raised thyroid-stimulating hormone levels and were treated with thyroxine (CHX-IA 0% vs PI 5%, p=0.003). CONCLUSIONS: We did not find a difference in the rate of CR-BSI between preterm infants treated with CHX-IA and PI, and more infants treated with PI had thyroid dysfunction. However, our study was not adequately powered to detect a difference in our primary outcome and a larger trial is required to confirm our findings. TRIAL REGISTRATION: This study was registered with the EU clinical trials register before the first patient was enrolled (Eudract 2011-002962-19). (https://www.clinicaltrialsregister.eu).

Positioning newborns on their back or right side for umbilical venous catheter insertion.

AIM: Newborns are placed supine for umbilical venous catheter insertion, and catheter tip position is confirmed with X-ray. Umbilical venous catheters are considered correctly positioned when the tip is in the inferior vena cava; however, frequently, the catheter tip enters the portal venous circulation. We wished to determine whether placing infants on their right side, rather than on the back, for umbilical venous catheter insertion results in more correctly placed catheters. METHODS: Newborns were randomised to be placed on their back, or turned onto their right side for catheter insertion. Primary outcome was correct catheter tip position on X-ray (visible in the midline at diaphragm level). RESULTS: Umbilical venous catheter insertion was successful in all infants enrolled. There was no difference in the proportion of correctly positioned catheters between the groups [back 23/44 (52%) versus right side 27/44 (61%), p = 0.389]. More infants randomised to back had the catheter tip in the portal circulation [back 13/44 (30%) versus right side 5/44 (11%), p = 0.034]. CONCLUSION: Positioning newborn infants on their right side did not result in more correctly placed umbilical venous catheters. The procedure was well tolerated and reduced the rate of tip insertion into the portal venous circulation.

A randomised trial of placing preterm infants on their back or left side after birth.

BACKGROUND: Basic life support guidelines recommend placing spontaneously breathing children and adults on their side. Though the majority of preterm newborns breathe spontaneously, they are routinely placed on their back after birth. We hypothesised that they would breathe more effectively when placed on their side. OBJECTIVE: To determine whether preterm newborns placed on their left side at birth, compared with those placed on their back, have higher preductal oxygen saturation (SpO2) at 5 min of life. DESIGN/METHODS: We randomised infants <32 weeks to be placed on their back or on their left side immediately after birth. Respiratory support was given with a T-piece and face mask with initial fraction of inspired oxygen (FiO2) of 0.3. The FiO2 was increased if SpO2 was <70% at 5 min. RESULTS: We enrolled 87 infants, 41 randomised to back and 46 to left side. The groups were well matched for demographic variables. Fourteen (6 back and 8 left side) infants did not receive respiratory support in the first 5 min. The mean (SD) SpO2 was not different between the groups (back 72 (23) % versus left side 71 (24) %, p=0.956). We observed no adverse effects of placing infants on their side and found no differences in secondary outcomes between the groups. CONCLUSIONS: Preterm infants on their left side did not have higher SpO2 at 5 min of life. Placing preterm infants on their side at birth is feasible and appears to be a reasonable alternative to placing them on their back. TRIAL REGISTRATION NUMBER: ISRCTN74486341.

Estimating umbilical catheter insertion depth in newborns using weight or body measurement: a randomised trial.

OBJECTIVE: Incorrectly positioned umbilical venous and arterial catheters (UVC and UAC) are associated with increased rates of complications in newborns. Catheter insertion depth is often estimated using body surface measurement. We wished to determine whether estimating insertion depth of umbilical catheters using birth weight (BW), rather than surface measurements, results in more correctly positioned catheters. INTERVENTIONS/OUTCOME: Newborns were randomised to have UVC and UAC insertion depth estimated using formulae based on BW or using graphs based on shoulder-umbilicus length. The primary outcome was correct catheter tip position on X-ray determined by one radiologist masked to group assignment. RESULTS: UVC insertion was successful in 97/101 (96%) infants but the catheter was not advanced to the estimated depth in 22. There was no difference in the proportion of correctly positioned UVCs between groups (weight 16/51 (31%) vs measurement 13/46 (28%), p=0.826). The tips of 52 (54%) UVCs were in the portal venous system or too low on X-ray. Attempted UAC insertion was successful in 62/87 (71%) infants. More infants in the weight group had a correctly positioned UAC tip (weight 29/32 (91%) vs measurement 15/30 (50%), p=0.001). CONCLUSIONS: UVCs were often not inserted to the estimated depth, and their tips were in the portal venous system or too low on X-ray. Using BW to estimate insertion depth did not result in more correctly positioned UVCs. UAC insertion attempts were often unsuccessful, but when successful, using BW to estimate insertion depth resulted in more correctly positioned catheters. TRIAL REGISTRATION NUMBER: (ISRCTN17864069).

Unlicensed and off-label drug use in an Irish neonatal intensive care unit: a prospective cohort study.

AIM: Many drugs are not licensed for use in children and drugs that are licensed may be given to them in an unapproved manner. We wanted to determine the extent of unlicensed and off-label prescribing in our neonatal intensive care unit (NICU). METHODS: All infants admitted to our tertiary-level NICU over 2 months were prospectively studied. We recorded demographic data, and all the drugs prescribed and compared the use of each drug to the licensed indications in the Summary of Product Characteristics. RESULTS: All the 110 infants admitted received a prescribed drug, with 69 different drugs prescribed, a median (IQR) of four (range: 3-11) drugs each. Just less than a fifth (19%) were unlicensed and 39% were off-label, with 45 infants (44%) receiving both an unlicensed and off-label drug, three (3%) receiving an unlicensed drug and 35 (32%) receiving just an off-label drug. Most infants <32 weeks received unlicensed (91%) and off-label (94%) drugs, and all infants <28 weeks received an unlicensed and an off-label drug. CONCLUSION: Most drugs prescribed to newborns are unlicensed or used for off-label reasons. Many infants, and the majority of preterm infants, admitted to our NICU received unlicensed and off-label drugs.

Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants.

OBJECTIVE: To determine whether nasal continuous positive airway pressure (NCPAP) given with nasal prongs compared with nasal mask reduces the rate of intubation and mechanical ventilation in preterm infants within 72 hours of starting therapy. METHODS: Infants <31 weeks' gestation treated with NCPAP were randomly assigned to receive it via either prongs or mask. Randomization was stratified by gestational age (<28 weeks, 28-30 weeks) and according to whether NCPAP was started as a primary treatment for respiratory distress or postextubation. Infants were intubated and ventilated if they fulfilled 2 or more of 5 failure criteria (worsening signs of respiratory distress; recurrent apnea treated with mask positive pressure ventilation; fraction of inspired oxygen >0.4 to keep oxygen saturation >88% sustained for 30 minutes; pH <7.2 on 2 blood gases ≥ 30 minutes apart; Pco(2) >9 kPa [68 mm Hg] on 2 blood gases ≥ 30 minutes apart) within 72 hours of starting therapy. The groups were treated the same in all other respects. We recorded relevant secondary outcomes and analyzed data by using the intention-to-treat principle. RESULTS: We enrolled 120 infants. Thirty-two of 62 (52%) infants randomly assigned to prongs were intubated within 72 hours, compared with 16/58 (28%) of those randomly assigned to mask (P = .007). There were no statistically significant differences between the groups in any secondary outcomes. CONCLUSIONS: In premature infants, NCPAP was more effective at preventing intubation and ventilation within 72 hours of starting therapy when given via nasal masks compared with nasal prongs.