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NCT06153459 · ClinicalTrials.gov registry record · NA
Cord Clamping Among Neonates With Congenital Heart Disease
A NA study of Congenital Heart Disease (CHD), sponsored by Carl Backes, MD.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06153459: Recruiting NA study of Congenital Heart Disease (CHD), sponsored by Carl Backes, MD.
NCT06153459 is a NA study of Congenital Heart Disease (CHD) that is actively recruiting participants, run by Carl Backes, MD. The registered enrollment target is 500 participants, above the 51-participant average among 3 other Congenital Heart Disease (CHD) trials with a reported enrollment target (880% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06153459, a NA study of Congenital Heart Disease (CHD), is actively recruiting participants, sponsored by Carl Backes, MD.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: * Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed Cord Clamping at 30 seconds (DCC-30) after birth lead to better health outcomes? * Does DCC-120 seconds or DCC-30 seconds after birth lead to better neuromotor outcomes at 22-26 months of infant age (postnatal)? Participants will be asked to do the following: * Participate in either DCC-120 or DCC-30 at birth (randomized assignment). * Complete General Movements Assessment (GMA) at 3-4 months of infant age (postnatal), complete questionnaires / surveys at this time. * Complete questionnaires / surveys at 9-12 months of infant age (postnatal). * Complete Hammersmith Infant Neurological Examination (HINE), Developmental Assessment of Young Children 2 Edition (DAYC-2), and questionnaires / surveys at 22-26 months of infant age (postnatal). * Permit data collection from electronic medical records for both the mother and infant study participants. Investigators will compare DCC-120 vs. DCC-30 to see which approach is more beneficial to both the mother and baby with CHD.
Primary Outcome
Mortality=97;Heart transplant=96;Complication preventing cardiac intervention=95;Pre or Post-intervention neurologic complication=95;Pre or Post-intervention respiratory failure w/tracheostomy=95;Renal failure permanent dialysis=95;Unplanned cardiac surgery after initial cardiac intervention=94;Cardiac arrest=94;Pre or Post-intervention multisystem organ failure=94;Mechanical circulatory support=94;Pre-intervention polycythemia w/exchange transfusion/hemodilution=93;Unplanned cardiac catheteriza
Conditions Studied
Interventions
- PROCEDURE Umbilical Cord Clamping at ~30 seconds
- PROCEDURE Umbilical Cord Clamping at ~120 seconds
- PROCEDURE Umbilical Cord Milking
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford - Palo Alto
- Sharp Mary Birch Hospital for Woman and Newborns - San Diego
Missouri
- The Children's Mercy Hospital - Kansas City
- SSM Health Cardinal Glennon Children's Hospital - St Louis
Texas
- Texas Children's Hospital - Houston
- University of Texas Health Science Center at San Antonio - San Antonio
Alabama
- Children's of Alabama - Birmingham
Florida
- UF Health Shands Children's Hospital - Gainesville
Maryland
- Johns Hopkins Children's Center - Baltimore
Mississippi
- Children's of Mississippi - Jackson
North Carolina
- Duke Children's Hospital & Health Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-12-19 |
| Est. Completion | 2030-12 |
| Phase | NA |
What NCT06153459 shows while recruiting
NCT06153459 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 51-participant average among 3 other Congenital Heart Disease (CHD) trials with a reported enrollment target (880% higher).
The record links to 1 condition, with Congenital Heart Disease (CHD) appearing as the primary indexed condition, and to 3 interventions - of which Umbilical Cord Clamping at ~30 seconds is the first listed.
NCT06153459 names 20 study sites across 15 states, led by California, Missouri, Texas.
Frequently Asked Questions
What is clinical trial NCT06153459 about?
NCT06153459 is a clinical study titled "Cord Clamping Among Neonates With Congenital Heart Disease". The goal of this clinical trial is to compare 2 different timepoints for clamping the umbilical cord at birth for term-born infants with a prenatal diagnosis of congenital heart disease (CHD). The main questions it aims to answer are: * Does Delayed Cord Clamping at 120 seconds (DCC-120) or Delayed...
What is the current status of trial NCT06153459?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2023-12-19. Estimated completion is 2030-12.
What conditions does trial NCT06153459 study?
This clinical trial studies the following conditions: Congenital Heart Disease (CHD).
What interventions are being tested in trial NCT06153459?
The interventions under investigation include: Umbilical Cord Clamping at ~30 seconds (PROCEDURE), Umbilical Cord Clamping at ~120 seconds (PROCEDURE), Umbilical Cord Milking (PROCEDURE).
Who is sponsoring clinical trial NCT06153459?
This trial is sponsored by Carl Backes, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06153459 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Maryland, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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