Cord Clamping Among Neonates With Congenital Heart Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age37-42
SponsorCarl Backes, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted on or after 18 weeks of gestation and prior to randomization. The study fetal diagnosis of CHD must be rated as 3 - 6 on the Fetal Cardiovascular Disease Severity Score (FCDSS), as determined by independent evaluators at the CORD-CHD trial ECHO Core at the Children's Hospital of Philadelphia (to determine final FCDSS eligibility for randomization).

Singleton gestation.

Gestational age at randomization for impending deliveries between 37 0/7 - 41 6/7 weeks of gestation inclusive based on clinical information and evaluation of the earliest ultrasound determined using criteria proposed by the American Congress of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine and the Society for Maternal-Fetal Medicine.

Consent for the participant and their infant

Disqualifiers

Pregnant individual is a gestational carrier or surrogate.

Compromise of the pregnant individual (e.g., vasa previa, placental accreta with hypotension, placental abruption, amniotic fluid embolism, uterine rupture, uterine inversion, disseminated intravascular coagulation), as determined by local care team

Fetal demise or planned termination of pregnancy prior to randomization

Tachyarrhythmia requiring transplacental therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Umbilical Cord Clamping at ~30 seconds

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Delayed Cord Clamping at 30 Seconds (DCC-30)Active comparator 1 intervention
Group B: Delayed Cord Clamping at 120 Seconds (DCC-120)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Global Rank Score (Infant participant)

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 catheterization after initial cardiac intervention=93;Pre-intervention mechanical ventilation=93;Pre-intervention necrotizing enterocolitis(Bell's II/III)=93;Pre-intervention shock=93;Pre-intervention unplanned hospitalization=93;Post-intervention bleeding reoperation=93;Delayed sternal closure=93;Pre-intervention renal failure temporary dialysis=93;Post-intervention renal failure, temporary dialysis=92;Post-intervention mechanical ventilation \>7 days=92;Hospital length of stay \>90 days=91,1-90 days=1-90

Time frame
Up to 30 days post-discharge following congenital heart disease intervention

Secondary outcomes

1

Neuromotor Outcomes at 3-4 months of age (Infant participant)

General Movements Assessment (GMA): The General Movements Assessment is used to identify absent or abnormal general movements in infants. General movements are spontaneous movements exhibited during fetal development and through the first 6 months of life after birth. Trained investigators will evaluate the infants general movements as: 1) Fidgety present; 2) Fidgety abnormal; and 3) Absent fidgety where "Fidgety present" is considered normal, and the other two outcomes are considered abnormal.

Time frame
3-4 months after birth
2

Impact of infant's congenital heart disease (Parents / Caregivers)

Questionnaire/Survey on the impact of infant's congenital heart disease upon the family dynamic; Impact on Family Scale - Revised: The Impact on Family Scale - Revised is a questionnaire for parents / caregivers used to evaluate perceptions of the impact of an infant's chronic medical condition (e.g., congenital heart disease) upon the family. The IFS-R uses a 4-point Likert-type scale (strongly agree to strongly disagree) for responses. High scores correlate with parental / caregiver stressors and psychiatric symptoms, poor infant health, and increased pediatric hospitalizations and/or health maintenance requirement, representing worse outcomes.

Time frame
3-4 months after birth
3

Impact of infant's congenital heart disease (Parents / Caregivers)

Questionnaire/Survey on the impact of infant's congenital heart disease upon the family dynamic; Functional Status II - Revised, Short Form: The Functional Status II - Revised, Short Form will be used to evaluate the functional status of infants that have been diagnosed with and undergone treatment for congenital heart disease. This survey, completed by parents / caregivers, is used to evaluate a core of 14 items using a 3-point Likert scale. The respondent (parent / caregiver) first rates the extent of difficulty with specific behaviors that the infant experiences, and then rates for those behaviors with difficulty, the extent to which the difficulty is due to the infants chronic illness. Higher scores generally indicate a reduced burden of chronic heart disease impacting the family, and therefore, a better outcome.

Time frame
3-4 months after birth
4

Impact of infant's congenital heart disease (Parents / Caregivers)

Questionnaire/Survey on the impact of infant's congenital heart disease upon the family dynamic; Impact on Family Scale - Revised: The Impact on Family Scale - Revised is a questionnaire for parents / caregivers used to evaluate perceptions of the impact of an infant's chronic medical condition (e.g., congenital heart disease) upon the family. The IFS-R uses a 4-point Likert-type scale (strongly agree to strongly disagree) for responses. High scores correlate with parental / caregiver stressors and psychiatric symptoms, poor infant health, and increased pediatric hospitalizations and/or health maintenance requirement, representing worse outcomes.

Time frame
9-12 months after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Carl Backes, MD

Lead sponsor

Nationwide Children's Hospital

Sponsor institution

The George Washington University Biostatistics Center

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Emory University

Collaborator

Boston Children's Hospital

Collaborator

University of Bristol

Collaborator

Geisinger Commonwealth School of Medicine

Collaborator

Duke University

Collaborator

Children's Hospital of Philadelphia

Collaborator

Sharp Mary Birch Hospital for Women & Newborns

Collaborator

Université de Montréal

Collaborator