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

NCT03242044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-06-14

No results posted yet for this study

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.

Conditions

  • Congenital Diaphragmatic Hernia

Interventions

PROCEDURE

Congenital diaphragmatic hernia resuscitation with an intact umbilical cord

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jason Gien, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2020-10-21
Completion
2020-10-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242044 on ClinicalTrials.gov