Cord Clamping Among Neonates With Congenital Heart Disease

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.

Conditions

• Congenital Heart Disease (CHD)

Interventions

PROCEDURE

Umbilical Cord Clamping at ~30 seconds

Care team will wait to clamp the umbilical between 1-\<60 seconds after birth. 30 seconds is the ideal time of clamping.

PROCEDURE

Umbilical Cord Clamping at ~120 seconds

Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping

PROCEDURE

Umbilical Cord Milking

For infants who need their cord clamped before the target in the DCC-120 group. Care team may milk the umbilical cord towards the infant four times. Cord milking should NOT be performed if the delay meets or exceeds 60 seconds. Umbilical cord milking will not be provided among participant-infant dyads in the DCC-30 group.

Sponsors & Collaborators

• The George Washington University Biostatistics Center

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Emory University

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Geisinger Commonwealth School of Medicine

  collaborator UNKNOWN

• Duke University

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Sharp Mary Birch Hospital for Women & Newborns

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• Carl Backes, MD

  lead OTHER

Principal Investigators

• Carl Backes, MD · Nationwide Children's Hospital

• Anup Katheria, MD · Sharp Mary Birch Hospital for Women & Newborns

• Kevin Hill, MD · Duke Children's Hospital

• Madeline Rice, PhD · George Washington University Biostatistics Center

• Grecio (Greg) Sandoval, PhD · George Washington University Biostatistics Center

• Scott Evans, PhD · George Washington University Biostatistics Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

37 Weeks

Max Age

42 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-19

Primary Completion

2028-10-31

Completion

2030-12-31

Countries

• United States
• Canada

Study Locations