Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood. (Funded by the United Kingdom Medical Research Council and others; TOBY ClinicalTrials.gov number, NCT01092637.).

SummaryBackgroundModerate cooling after birth asphyxia is associated with substantial reductions in death and disability, but additional therapies might provide further benefit. We assessed whether the addition of xenon gas, a promising novel therapy, after the initiation of hypothermia for birth asphyxia would result in further improvement.MethodsTotal Body hypothermia plus Xenon (TOBY-Xe) was a proof-of-concept, randomised, open-label, parallel-group trial done at four intensive-care neonatal units in the UK. Eligible infants were 36–43 weeks of gestational age, had signs of moderate to severe encephalopathy and moderately or severely abnormal background activity for at least 30 min or seizures as shown by amplitude-integrated EEG (aEEG), and had one of the following: Apgar score of 5 or less 10 min after birth, continued need for resuscitation 10 min after birth, or acidosis within 1 h of birth. Participants were allocated in a 1:1 ratio by use of a secure web-based computer-generated randomisation sequence within 12 h of birth to cooling to a rectal temperature of 33·5°C for 72 h (standard treatment) or to cooling in combination with 30% inhaled xenon for 24 h started immediately after randomisation. The primary outcomes were reduction in lactate to N-acetyl aspartate ratio in the thalamus and in preserved fractional anisotropy in the posterior limb of the internal capsule, measured with magnetic resonance spectroscopy and MRI, respectively, within 15 days of birth. The investigator assessing these outcomes was masked to allocation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00934700, and with ISRCTN, as ISRCTN08886155.FindingsThe study was done from Jan 31, 2012, to Sept 30, 2014. We enrolled 92 infants, 46 of whom were randomly assigned to cooling only and 46 to xenon plus cooling. 37 infants in the cooling only group and 41 in the cooling plus xenon group underwent magnetic resonance assessments and were included in the analysis of the primary outcomes. We noted no significant differences in lactate to N-acetyl aspartate ratio in the thalamus (geometric mean ratio 1·09, 95% CI 0·90 to 1·32) or fractional anisotropy (mean difference −0·01, 95% CI −0·03 to 0·02) in the posterior limb of the internal capsule between the two groups. Nine infants died in the cooling group and 11 in the xenon group. Two adverse events were reported in the xenon group: subcutaneous fat necrosis and transient desaturation during the MRI. No serious adverse events were recorded.InterpretationAdministration of xenon within the delayed timeframe used in this trial is feasible and apparently safe, but is unlikely to enhance the neuroprotective effect of cooling after birth asphyxia.FundingUK Medical Research Council.

Aim: To review the evidence on safety of maintaining family integrated care practices and the effects of restricting parental participation in neonatal care during the SARS-CoV-2 pandemic. Methods: MEDLINE, EMBASE, PsycINFO and CINAHL databases were searched from inception to the 14th of October 2020. Records were included if they reported scientific, empirical research (qualitative, quantitative or mixed methods) on the effects of restricting or promoting family integrated care practices for parents of hospitalised neonates during the SARS-CoV-2 pandemic. Two authors independently screened abstracts, appraised study quality and extracted study and outcome data. Results: We retrieved 803 publications and assessed 75 full-text articles. Seven studies were included, reporting data on 854 healthcare professionals, 442 parents, 364 neonates and 26 other family members, within 286 neonatal units globally. The pandemic response resulted in significant changes in neonatal unit policies and restricting parents' access and participation in neonatal care. Breastfeeding, parental bonding, participation in caregiving, parental mental health and staff stress were negatively impacted. Conclusion: This review highlights that SARS-CoV-2 pandemic-related hospital restrictions had adverse effects on care delivery and outcomes for neonates, families and staff. Recommendations for restoring essential family integrated care practices are discussed. K E Y W O R D S family integrated care, family centred care, SARS-CoV-2, COVID-19, neonatal, parent | 2009 van vEEnEnDaaL Et aL.

ObjectiveThe aim of the Integrated Family Delivered Care (IFDC) programme was to improve infant health outcomes and parent experience through education and competency-based training.DesignIn collaboration with veteran parents’ focus groups, we created an experienced co-designed care bundle including IFDC mobile application, which together with staff training programme comprised the IFDC programme. Infant outcomes were compared with retrospective controls in a prepost intervention analysis.Main outcome measuresThe primary outcome measure was the length of stay (LOS).ResultsBetween April 2017 and May 2018, 89 families were recruited; 37 infants completed their entire care episode in our units with a minimum LOS >14 days. From a gestational age (GA) and birth weight-matched retrospective cohort, 57 control infants were selected. Data were also analysed for subgroup under 30 weeks GA (n=20).Infants in the IFDC group were discharged earlier: median corrected GA (36+0 (IQR 35+0–38+0) vs 37+1 (IQR 36+3–38+4) weeks; p=0.003), with shorter median LOS (41 (32–63) vs 55 (41–73) days; p=0.022). This was also evident in the subgroup <30 weeks GA (61 (39–82) vs 76 (68–84) days; p=0.035). Special care days were significantly lower in the IFDC group (30 (21–41) vs 40 (31–46); p=0.006). The subgroup of infants (<30 weeks) reached full suck feeding earlier (median: 47 (37–76) vs 72 (66–82) days; p=0.006).ConclusionThis is the first reported study from a UK tertiary neonatal unit demonstrating significant benefits of family integrated care programme. The IFDC programme has significantly reduced LOS, resulted in the earlier achievement of full enteral and suck feeds.

How should health professionals engage with this increasingly popular but unproved practice?