Cord Clamping Among Neonates With Congenital Heart Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Carl Backes, MD
Study ID
NCT06153459
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease (CHD)

Eligibility Criteria

Sex
ALL
Age
37 Weeks - 42 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Umbilical Cord Clamping at ~30 seconds — PROCEDURE
    Care team will wait to clamp the umbilical between 1-\<60 seconds after birth. 30 seconds is the ideal time of clamping.
  • Umbilical Cord Clamping at ~120 seconds — PROCEDURE
    Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping
  • Umbilical Cord Milking — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Dec 19, 2023
Status verified
Jul 2025
Primary completion
Oct 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Delayed Cord Clamping at 30 Seconds (DCC-30)
    The umbilical cord will be clamped between 1 - \<60 seconds following delivery, with a goal of around 30 seconds.
  • Active Comparator: Delayed Cord Clamping at 120 Seconds (DCC-120)
    The umbilical cord will be clamped at 60 - 180- seconds following delivery, with a goal of around 120 seconds. In the DCC-120 group, if there is concern for pregnant individual or baby and their doctor is not able to wait until at least 60 seconds, the doctor may do cord milking, which is four gentle squeezes of the umbilical cord pushing blood from the placenta to baby.

Primary Outcome Measure

Global Rank Score (Infant participant) [ Time Frame: Up to 30 days post-discharge following congenital heart disease intervention ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233
Andrea Kane, MD
[email protected]
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Ruchira Garg, MD
[email protected]
Children's Hospital of Orange CountyOrangeCalifornia92868
Shawn Sen, MD
[email protected]
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304
Alexis Davis, MD
[email protected]
Sharp Mary Birch Hospital for Woman and NewbornsSan DiegoCalifornia92123
Anup Katheria, MD
[email protected]
Jenny Koo, MD
[email protected]
Anup Katheria, MD (PRINCIPAL_INVESTIGATOR)
Jenny Koo, MD (PRINCIPAL_INVESTIGATOR)
UF Health Shands Children's HospitalGainesvilleFlorida32608
Jennifer Co-Vu, MD
[email protected]
Johns Hopkins Children's CenterBaltimoreMaryland21287
Victoria Surma, MD
[email protected]
Children's of MississippiJacksonMississippi39216
Simon Karam, MD
[email protected]
The Children's Mercy HospitalKansas CityMissouri64108
John Daniel, MD
[email protected]
SSM Health Cardinal Glennon Children's HospitalSt LouisMissouri63104
Justin Josephsen, MD
[email protected]
Duke Children's Hospital & Health CenterDurhamNorth Carolina27705
Kevin Hill, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205
Carl H. Backes, MD
[email protected]
6142646374
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Elizabeth Foglia, MD
[email protected]
Medical University of South CarolinaColumbiaSouth Carolina29209
Sinai Zyblewski, MD
[email protected]
Monroe Carell Jr. Children's Hospital at VanderbiltNashvilleTennessee37232
Prince Kannankeril, MD
[email protected]
Texas Children's HospitalHoustonTexas77030
Nathan Sundgren, MD, PhD
[email protected]
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
J.B. Cantey, MD
[email protected]
Primary Children's HospitalSalt Lake CityUtah84113
Ryan Carpenter, MD
[email protected]

Find similar trials in Birmingham, AL

By research site
Children's of Alabama· Birmingham, ALCedars-Sinai Medical Center· Los Angeles, CAChildren's Hospital of Orange County· Orange, CALucile Packard Children's Hospital Stanford· Palo Alto, CASharp Mary Birch Hospital for Woman and Newborns· San Diego, CAUF Health Shands Children's Hospital· Gainesville, FL

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