Cord Clamping Among Neonates With Congenital Heart Disease — CORD-CHD  

Congenital Heart Disease (CHD) Clinical Trial

Official title: CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Congenital Heart Disease (CHD)
• Heart Defects, Congenital
• Heart Diseases

• NCT number: NCT06153459
• Study type: Interventional
• Source: Nationwide Children's Hospital
• Contact: Carl Backes, MD
• Phone: 614-355-6729
• Email: carl.backes@nationwidechildrens.org
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2023
• Completion date: December 2030