Background Infants with congenital diaphragmatic hernia (CDH) often experience hypoxaemia with acidosis immediately after birth. The traditional approach in the delivery room is immediate cord clamping followed by intubation. Initiating resuscitation prior to umbilical cord clamping (UCC) may support this transition.
Objectives To establish the safety and feasibility of intubation and ventilation prior to UCC for infants with CDH. To compare short-term outcomes between trial participants and matched controls treated with immediate cord clamping before intubation and ventilation.
Design Single-arm, single-site trial of infants with CDH and gestational age ≥36 weeks. Infants were placed on a trolley immediately after birth and underwent intubation and ventilation, with UCC performed after qualitative CO2 detection. The primary feasibility endpoint was successful intubation prior to UCC. Prespecified safety and physiological outcomes were compared with historical controls matched for prognostic variables using standard bivariate tests.
Results Of 20 enrolled infants, all were placed on the trolley, and 17 (85%) infants were intubated before UCC. The first haemoglobin and mean blood pressure at 1 hour of life were significantly higher in trial participants than controls. There were no significant differences between groups for subsequent blood pressure values, vasoactive medications, inhaled nitric oxide or extracorporeal membrane oxygenation. Blood gas and oxygenation index values did not differ between groups at any point.
Conclusions Intubation and ventilation prior to UCC is safe and feasible among infants with CDH. The impact of this approach on clinically relevant outcomes deserves investigation in a randomised trial.
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Contributors The authors made the following contributions to this work: study design: EEF, AA, HLH, NR, DAM, JM, JG, BS, AC and SJR. Data collection and analysis: EEF, AC, DW, NN, MVF and SJR. Drafting Manuscript: EEF. Critically revise manuscript: all authors.
Funding EEF is supported by a National Institute of Child Health and Human Development Career Development Award, K23HD084727. NN receives research support from Draeger, Aerogen, Smiths Medical, Actuated Medical and Vero Biotech.
Competing interests EEF is an unpaid member of the Scientific Advisory board for Concord Neonatal. NN receives research support from Draeger, Aerogen, Smiths Medical, Actuated Medical and Vero Biotech. No other competing interests are declared.
Patient consent for publication Parental/guardian consent obtained.
Ethics approval This study was approved by the Children’s Hospital of Philadelphia Institutional Review Board (17–0 14 125).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.