Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants with Isolated Congenital Diaphragmatic Hernia (CHIC)

Abstract

Resuscitation at birth of infants with Congenital Diaphragmatic Hernia (CDH) remains highly challenging because of severe failure of cardiorespiratory adaptation at birth. Usually, the umbilical cord is clamped immediately after birth. Delaying cord clamping while the resuscitation maneuvers are started may: (1) facilitate blood transfer from placenta to baby to augment circulatory blood volume; (2) avoid loss of venous return and decrease in left ventricle filling caused by immediate cord clamping; (3) prevent initial hypoxemia because of sustained uteroplacental gas exchange after birth when the cord is intact. The aim of this trial is to evaluate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in infants with isolated CDH. The Congenital Hernia Intact Cord (CHIC) trial is a prospective multicenter open-label randomized controlled trial in two balanced parallel groups. Participants are randomized either immediate cord clamping (the cord will be clamped within the first 15 s after birth) or to intact cord resuscitation group (umbilical cord will be kept intact during the first part of the resuscitation). The primary end-point is the number of infants with APGAR score <4 at 1 min or <7 at 5 min. One hundred eighty participants are expected for this trial. To our knowledge, CHIC is the first study randomized controlled trial evaluating intact cord resuscitation on newborn infant with congenital diaphragmatic hernia. Better cardiorespiratory adaptation is expected when the resuscitation maneuvers are started while the cord is still connected to the placenta.

Editorial: Unsolved problems in congenital diaphragmatic hernia

“…Based on animal experiments and evaluation, the first breath and changes in lung inflation and the circulation at transition have resulted in two large randomized trials—Congenital Hernia Intact Cord (CHIC, NCT04429750) ( 9 ) and Physiological-based cord clamping for infants with a Congenital Diaphragmatic Hernia (PinC, NCT04373902) ( DeKoninck et al ) ( 10 )—to evaluate the effect of delayed, physiology-based cord clamping. Short-term outcomes such as Apgar scores (CHIC) and pulmonary hypertension (PinC) have been selected as primary outcomes.…”

Antenatal management of congenital diaphragmatic hernia: What's next ?

“…We are aware of two clinical trials investigating whether delayed cord clamping facilitates neonatal cardiovascular adaptation 61 . This should prevent early hypoxemia, increase circulatory blood volume and avoid loss of venous return and decrease in left ventricle filling, which is caused by immediate cord clamping (CHIC trial, NCT04429750 & Physiological‐based Cord Clamping in CDH, PinC, NCT04373902) 62 …”

Knowledge Gaps in the Fetal to Neonatal Transition of Infants With a Congenital Diaphragmatic Hernia

“…It is obviously not possible to draw firm conclusions, however both found improved cardiovascular adaptation, resulting in higher blood pressures, less need for cardiac resuscitation and higher Apgar scores ( 11 , 12 ). These promising findings led to the initiation of two large randomized trials: Congenital Hernia Intact Cord (CHIC, NCT04429750 ) and Physiological-based cord clamping for infants with a Congenital Diaphragmatic Hernia (PinC, NCT04373902 ) ( 21 ).…”

“…CO 2 detectors, respiratory monitors or bedside echocardiography (ductus arteriosus evaluation) could be used for this purpose, but they have inherent technical limitations or are logistically not always feasible in the immediate postnatal setting. Hence, physiological parameters such as heart rate, oxygen saturation and the level of oxygen supplementation are considered as a good alternate proxies for determining lung aeration and the state of the infant's cardiovascular adaptation ( 9 , 21 ). In the future, with the rapid improvement of bedside respiratory monitors, real-time evaluation of tidal volumes or other lung mechanics might be another way to ascertain adequate lung aeration.…”