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NCT03242044 · ClinicalTrials.gov registry record · NA
Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03242044: Completed NA study, sponsored by University of Colorado, Denver.
NCT03242044 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03242044, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
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.
Primary Outcome
10 maternal and infant with left or right sided congenital diaphragmatic hernia dyads will be enrolled in the study and maternal and infant tolerance to resuscitation with an intact umbilical cord determined. Maternal tolerance will be assessed by the incidence of post-partum hemorrhage and uterine atony, infant tolerance determined by capillary blood gas assessments of pH, pCO2 and base deficit and the incidence of bradycardia lasting greater than 1 minute.
Interventions
- PROCEDURE Congenital diaphragmatic hernia resuscitation with an intact umbilical cord
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-01-12 |
| Est. Completion | 2020-10-21 |
| Phase | NA |
What the finished NCT03242044 record still lists
NCT03242044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Congenital diaphragmatic hernia resuscitation with an intact umbilical cord is the first listed.
NCT03242044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03242044 about?
NCT03242044 is a clinical study titled "Resuscitation of Infants With Congenital Diaphragmatic Hernia With an Intact Umbilical Cord". 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 ...
What is the current status of trial NCT03242044?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2018-01-12. Estimated completion is 2020-10-21.
What interventions are being tested in trial NCT03242044?
The interventions under investigation include: Congenital diaphragmatic hernia resuscitation with an intact umbilical cord (PROCEDURE).
Who is sponsoring clinical trial NCT03242044?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03242044's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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