Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 2:58 PM
Study NCT ID:
NCT06153459
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2023-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cord Clamping Among Neonates With Congenital Heart Disease
Sponsor:
Carl Backes, MD
Organization:
Study Overview
Official Title:
CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORD-CHD
Brief 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.
* 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.
Detailed Description:
* AIM 1: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking of 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 results in lower global rank score (GRS), indicative of better health outcomes, compared with DCC-30.
* AIM 2: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking from 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 will result in better neuromotor outcomes at 22-26 months postnatal than DCC-30.
* AIM 2: Test the hypothesis that, among neonates with prenatally diagnosed significant CHD (ranking from 3 - 6 on the Fetal Cardiovascular Disease Severity Score \[FCDSS\]), DCC-120 will result in better neuromotor outcomes at 22-26 months postnatal than DCC-30.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UG3HL166794 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG3HL166799 | OTHER_GRANT | NHLBI | View |