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.
Highlights
We evaluated the safety, feasibility and impacts of intact cord resuscitation (ICR)
If the number of Serious Adverse Event (SAE) within the first 24 h after birth is twice higher in the “intact cord resuscitation” group after the inclusion of 30 patients, If the Data and Safety Monitoring Board (DSMB) judges that a reported SAE caused by the procedure requires to stop the study, If inclusion rate is less than 25% of the total inclusion objectives, 24 months after starting the inclusion in the study
Initiating resuscitation prior to umbilical cord clamping (UCC) may support this transition, to avoid the loss of venous return and decrease in left ventricle filling caused by cord clamping, ideally increase in pulmonary blood flow should precede cord clamping
Summary
Any delay between umbilical cord clamping and the increase in pulmonary blood flow could severely affect left ventricular output and potentially result in organ injury. In CDH infant, increase in pulmonary blood flow is delayed after birth because of PPHN. These changes may significantly impact on cardiac function after clamping of the cord. In 2015, the International Liaison Committee on Resuscitation (ILCOR) recommended that the cord should not be cut for at least 1 to 3 min after birth in infants not requiring resuscitation [9] This recommended change in practice is to facilitate blood transfer from placenta to baby to reduce iron deficiency and later anemia in the full-term newborn infant. A multicenter randomized clinical study is required to confirm the benefit of intact cord resuscitation in CDH infants on cardiorespiratory adaptation at birth. To know whether intact cord resuscitation improves initial cardiorespiratory adaptation at birth is a major issue
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