Cord Clamping Among Neonates With Congenital Heart Disease (CORD-CHD)
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| ClinicalTrials.gov Identifier: NCT06153459 |
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Recruitment Status :
Recruiting
First Posted : December 1, 2023
Last Update Posted : May 16, 2024
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Sponsor:
Carl Backes, MD
Collaborators:
The George Washington University Biostatistics Center
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Boston Children's Hospital
University of Bristol
Geisinger Commonwealth School of Medicine
Duke University
Children's Hospital of Philadelphia
Sharp Mary Birch Hospital for Women & Newborns
Université de Montréal
Information provided by (Responsible Party):
Carl Backes, MD, Nationwide Children's Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Heart Disease (CHD) | Procedure: Umbilical Cord Clamping at ~30 seconds Procedure: Umbilical Cord Clamping at ~120 seconds Procedure: Umbilical Cord Milking | Not Applicable |
- 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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease |
| Actual Study Start Date : | December 19, 2023 |
| Estimated Primary Completion Date : | October 2028 |
| Estimated Study Completion Date : | December 2030 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
Other Name: Randomized to DCC-30 Group |
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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. |
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
Other Name: Randomized to DCC-120 Group 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. |
Primary Outcome Measures :
- Global Rank Score (Infant participant) [ Time Frame: Up to 30 days post-discharge following congenital heart disease intervention ]Mortality=97; Heart transplant=96; Complication preventing cardiac intervention=95; Post-intervention neurologic complication=95; Post-intervention respiratory failure w/tracheostomy=95; Renal failure permanent dialysis=95; Unplanned cardiac surgery after initial cardiac intervention=94; Cardiac arrest=94; 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
Secondary Outcome Measures :
- Neuromotor Outcomes at 3-4 months of age (Infant participant) [ Time Frame: 3-4 months after birth ]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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 3-4 months after birth ]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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 3-4 months after birth ]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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 9-12 months after birth ]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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 9-12 months after birth ]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) 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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 22-26 months after birth ]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.
- Impact of infant's congenital heart disease (Parents / Caregivers) [ Time Frame: 22-26 months after birth ]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) 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.
- Neurodevelopmental Outcomes at 22-26 months (Infant participant) [ Time Frame: 22-26 months after birth ]Hammersmith Infant Neurological Exam (HINE): The Hammersmith Infant Neurological Examination (HINE) consists of 26 items that assess different aspects of infant neurological function. The maximal global (total) score is 78, divided among the following domains: cranial nerve function (maximum score 15); posture (maximum score 18); movements (maximum score 6); muscle tone (maximum score 24) and reflexes and reactions (maximum score 15). Higher scores indicate better expected outcomes.
- Neurodevelopmental Outcomes at 22-26 months (Infant participant) [ Time Frame: 22-26 months after birth ]Developmental Assessment of Young Children, 2nd Edition (DAYC-2): The Developmental Assessment of Young Children, Second Edition (DAYC-2) is used to evaluate infants and children over 5 domains: cognition; communication; social-emotional development; physical development; and adaptive behavior. The DAYC-2 uses a norm-referenced sample to establish standardized scores in each domain, allowing investigators to compare the results to infants of similar age. Percentile ranks, and age equivalents are provided for each domain. Elements are graded on a simple "Yes" or "No" scale, with "Yes" being 1 point and "No" being 0 points. In general, higher scores reflect better expected outcomes.
- Parental perspectives of outcomes (Parents / Caregivers) [ Time Frame: 22-26 months after birth ]Survey of parent / caregiver opinions of expectations and outcomes as it relates to their infant with congenital heart disease. This questionnaire will examine parental perspectives with regards to health and neurodevelopmental outcomes, as compared to those commonly used in pediatric medicine. For example, parents / caregivers may place greater emphasis upon their child being able to conduct physical activity as compared to how well they perform tasks (fine and gross neuromotor function). Additionally, parents may express concern for their infant being able to eat without requiring a feeding tube, or breathing without the need for assistance or additional oxygen support. The survey will also seek to determine areas in which parents / caregivers feel there is room for improvement as it applies to their infant. There is no formal "scale" for this survey, as responses are primarily open-ended, requiring descriptive content analysis.
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of postpartum hemorrhage (defined as blood loss >1L within 24 hours post-delivery)
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of prolonged 3rd stage of labor (defined as retention of placenta for >30 minutes postpartum)
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of use of medications for postpartum hemorrhage management other than oxytocin (e.g., methergine, tranexamic acid, hemabate, misoprostol)
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of requirement for uterine balloon tamponade or other surgical intervention to treat postpartum hemorrhage
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of requirements for manual placental removal
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of requirement for transfusion, post-partum
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Volume of transfusion required, if applicable
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Type of transfusion required (e.g., whole blood, red blood cells, platelets, etc.), if applicable
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of postpartum endometritis
- Delivery Complications and Outcomes (Pregnant individual participant) [ Time Frame: Through hospital discharge (up to 1 month) ]Incidence of mortality
Information from the National Library of Medicine
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| Ages Eligible for Study: | 37 Weeks to 42 Weeks (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria are listed below and will be confirmed prior to randomization:
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Fetal diagnosis of congenital heart disease (CHD) by prenatal ultrasound / echocardiography from local fetal ECHO, conducted between 18 - 36 weeks of gestation. 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).
For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 and 36 weeks of gestation for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.]
[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.]
- Singleton gestation.
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Gestational age at labor and delivery admission (randomization) 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.
[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window".]
- Informed consent to participate for both the pregnant individual and their infant
Exclusion criteria are listed below and will be confirmed prior to randomization:
Exclusion Criteria for Pregnant Individuals:
- 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
[NOTE: There is no limitation on pregnant individual's age]
Fetal Exclusion Criteria:
- Fetal demise or planned termination of pregnancy prior to randomization
- Tachyarrhythmia requiring transplacental therapy
- Fetal hydrops, severe
- Autoimmune myocardial disease
- Planned fetal surgery
- Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
- Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
- Neuromuscular disorders (e.g., holoprosencephaly)
- Parents choosing to limit treatment
Pregnancy Exclusion Criteria:
- Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site
- Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06153459
Contacts
| Contact: Carl Backes, MD | 614-355-6729 | carl.backes@nationwidechildrens.org | |
| Contact: Chelsea E Cobe, BA | 614-355-6651 | chelsea.cobe@nationwidechildrens.org |
Locations
Show 21 study locations
Sponsors and Collaborators
Carl Backes, MD
The George Washington University Biostatistics Center
National Heart, Lung, and Blood Institute (NHLBI)
Emory University
Boston Children's Hospital
University of Bristol
Geisinger Commonwealth School of Medicine
Duke University
Children's Hospital of Philadelphia
Sharp Mary Birch Hospital for Women & Newborns
Université de Montréal
Investigators
| Principal Investigator: | Carl Backes, MD | Nationwide Children's Hospital | |
| Principal Investigator: | Anup Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | |
| Principal Investigator: | Kevin Hill, MD | Duke Children's Hospital | |
| Principal Investigator: | Madeline Rice, PhD | George Washington University Biostatistics Center | |
| Principal Investigator: | Grecio (Greg) Sandoval, PhD | George Washington University Biostatistics Center | |
| Principal Investigator: | Scott Evans, PhD | George Washington University Biostatistics Center |
Publications:
| Responsible Party: | Carl Backes, MD, Principal Investigator, Nationwide Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT06153459 |
| Other Study ID Numbers: |
STUDY00003337 UG3HL166794 ( U.S. NIH Grant/Contract ) UG3HL166799 ( Other Grant/Funding Number: NHLBI ) |
| First Posted: | December 1, 2023 Key Record Dates |
| Last Update Posted: | May 16, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data will be made available per NIH/NHLBI requirements (National Heart, Lung, and Blood Institute) |
| Supporting Materials: |
Statistical Analysis Plan (SAP) |
| Time Frame: | 2 years after primary publication |
| Access Criteria: | An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NIH/NHLBI program staff to develop a broad data sharing plan over time. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Carl Backes, MD, Nationwide Children's Hospital:
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cord clamping echocardiography (ECHO) congenital heart disease (CHD) CORD-CHD |
Additional relevant MeSH terms:
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Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |