Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord
Completed · Not applicable
Conditions studied: Congenital Diaphragmatic Hernia
In brief
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.
Key facts
- Study ID
- NCT03242044
- Run by
- University of Colorado, Denver
- People needed
- 10
- Starts
- 2018-01-12
- Expected to finish
- 2020-10-21
- Last updated by the study team
- 2021-06-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pregnant women 18 years of age and older with a fetus with the diagnosis of left and right sided congenital diaphragmatic hernia who consent to the protocol.
You may not qualify if…
- Patients with Morgagni type defects.
- Infants that have undergone fetal endoscopic tracheal occlusion (FETO)
- Infants with CDH with chromosomal anomalies trisomy 18 and 13
- Infants with bilateral congenital diaphragmatic hernia
Where it is running
- Children's Hospital Colorado — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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