CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Congenital diaphragmatic hernia resuscitation with an intact umbilical cordprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03242044
NCT03242044N/ACompleted

Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord

University of Colorado, Denver·interventional·Posted Aug 8, 2017·Updated Jun 14, 2021

In Brief

A clinical study evaluating Congenital diaphragmatic hernia resuscitation with an intact umbilical cord for Congenital Diaphragmatic Hernia. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Congenital diaphragmatic hernia (CDH) is a severe birth defect, with a prevalence of 1:2000 to 1:3000 live births where a defect in the diaphragm results in, herniation of the abdominal contents into the chest with subsequent compression of the intrathoracic structures and respiratory insufficiency after birth. Respiratory insufficiency is managed with intubation and mechanical ventilation. In addition to managing respiratory insufficiency, intubation prevents entrainment of air into the intestines and further compression of the lungs and heart. Resuscitation of infants with CDH also involves placement of a nasogastric tube (NG) into the stomach for removal of entrained air and secretions. As part of routine resuscitation in infants with CDH intubation and NG tube placement are performed after the delivery personnel separates the baby from the placenta by cutting the umbilical cord. This study will assess the feasibility, maternal and fetal tolerance and the optimal approach to performing these initial steps of resuscitation with an intact umbilical cord. The investigators have randomly chosen 10 maternal and infant with congenital diaphragmatic hernia dyads to demonstrate feasibility as well as determine pitfalls and difficulties and the optimal approach to a complex resuscitation with an intact umbilical cord.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 8, 2017
Enrollment StartJan 12, 2018
Primary CompletionOct 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.9 years ago

Interventions

Congenital diaphragmatic hernia resuscitation with an intact umbilical cordprocedure

10 infants with left or right sided congenital diaphragmatic hernia will be intubated and ventilation initiated while still attached to the placental circulation through the umbilical cord. In addition, at the same time, a nasogastric tube will be placed in the stomach to drain entrained air and secretions. After 5 minutes of resuscitation with the umbilical cord intact, the umbilical cord will be cut, infants separated from the placenta and resuscitation performed per routine neonatal resuscitation protocols. Feasibility, the optimal approach and maternal and infant tolerance to the procedure will be assessed as part of the study.