Initiation of Resuscitation While Attached to the Cord With Congenital Diaphragmatic Hernia

Study Overview
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Brief Summary
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This study aims to measure the cardio-respiratory physiological consequences of initiating resuscitation during placental transfusion (PT) with an intact umbilical cord in infants with congenital diaphragmatic hernia (CDH). PT, mainly via delayed cord clamping, has been shown to offer a higher circulating blood volume, less need for blood transfusion, less need for inotropes in infants. Currently infants with CDH receive immediate cord clamping (ICC) to facilitate immediate resuscitation including immediate intubation and mechanical ventilation. With the development of a resuscitation platform (iNSPiRE), resuscitative care can now be commenced from birth in infants with CDH to benefit from PT.

Official Title
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Initiation of Resuscitative Care While on Placental Circulation for Infants With Congenital Diaphragmatic Hernia - a Randomized Pilot Trial

Conditions
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Congenital Diaphragmatic Hernia

Intervention / Treatment
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* Procedure: Ventilatory support while attached to the cord
* Procedure: Immediate cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn infants with an antenatal diagnosed CDH. Exclusion Criteria: Severe antepartum or postpartum hemorrhage. Any obstetrical concern. Lack of parental consent.

Ages Eligible for Study
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Maximum Age: 10 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilatory support while attached to the cord<br>Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care. | Procedure: Ventilatory support while attached to the cord<br>* Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care.<br>|
| Active Comparator: Immediate cord clamping<br>Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol. | Procedure: Immediate cord clamping<br>* Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of infants with hypotension requiring inotropes | Proportion of infants with hypotension requiring inotropes in the first 24 hours after birth in the neonatal intensive care unit. | first 24 hours after birth |