Congenital Heart Disease (CHD)CORD-CHDNCT06153459
Cord Clamping Among Neonates With Congenital Heart Disease
A study testing Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds and Umbilical Cord Milking in people with Congenital Heart Disease (CHD), run by Carl Backes, MD at 21 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds and Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 19 Dec 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Show all 15Show fewer
- Fetal hydrops, severe
- Planned fetal surgery
- Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
- Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
- Disease or disorder impacting candidacy for neonatal cardiac interventions
- 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
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 2 countries
United States18 sites, 18 recruiting
- Recruiting
Johns Hopkins Children's Center
Baltimore, Maryland, 21287
Victoria Surma, MD, vsurma1@jhmi.edu
Victoria Surma, MD
- Recruiting
Children's of Alabama
Birmingham, Alabama, 35233
Andrea Kane, MD, akane@uabmc.edu
Andrea Kane, MD
- Recruiting
Medical University of South Carolina
Columbia, South Carolina, 29209
Sinai Zyblewski, MD, chois@musc.edu
Sinai Zyblewski, MD
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Carl H. Backes, MD, 6142646374, Carl.Backes@nationwidechildrens.org
Carl Backes, MD
- Recruiting
Duke Children's Hospital & Health Center
Durham, North Carolina, 27705
Kevin Hill, kevin.hill@duke.edu
Kevin Hill, MD
- Recruiting
UF Health Shands Children's Hospital
Gainesville, Florida, 32608
Jennifer Co-Vu, MD, jcovu@mail.ufl.edu
Jennifer Co-Vu, MD
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Nathan Sundgren, MD, PhD, ncsundgr@texaschildrens.org
Nathan Sundgren, MD, PhD
- Recruiting
Children's of Mississippi
Jackson, Mississippi, 39216
Simon Karam, MD, skaram@umc.edu
Simon Karam, MD
- Recruiting
The Children's Mercy Hospital
Kansas City, Missouri, 64108
John Daniel, MD, jmdaniel@cmh.edu
John Daniel, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Ruchira Garg, MD, ruchira.garg@cshs.org
Ruchira Garg, MD
- Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Prince Kannankeril, MD, prince.kannankeril@vumc.org
Prince Kannankeril, MD
- Not yet recruiting
Children's Hospital of Orange County
Orange, California, 92868
Shawn Sen, MD, shawn.sen@choc.org
- Not yet recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
Alexis Davis, MD, asdavis@stanford.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Elizabeth Foglia, MD, foglia@chop.edu
Elizabeth Foglia, MD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Ryan Carpenter, MD, ryan.carpenter@hsc.utah.edu
Ryan Carpenter, MD
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
J.B. Cantey, MD, cantey@uthsca.edu
J.B. Cantey, MD
- Recruiting
Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California, 92123
Anup Katheria, MD, anup.katheria@sharp.com
Jenny Koo, MD, Jenny.Koo@sharp.com
- Recruiting
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
Justin Josephsen, MD, justin.josephsen@health.slu.edu
Justin Josephsen, MD
Canada3 sites, 3 recruiting
- Recruiting
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta
Brenda Law, MD, blaw2@ualberta.ca
Brenda Law, MD
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
Walid El-Naggar, MD, walid.el-naggar@iwk.nshealth.ca
Walid El-Naggar, MD
- Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario
Michael Seed, MBBS, mike.seed@sickkids.ca
Michael Seed, MBBS
About this study
Official title: CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
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)?
Read more
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.
Read the detailed 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds, Umbilical Cord Milking
- Keywords
- cord clamping, echocardiography (ECHO), congenital heart disease (CHD), CORD-CHD
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Clamping at ~30 secondsProcedure or surgery
Also called Randomized to DCC-30 Group
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 secondsProcedure or surgery
Also called Randomized to DCC-120 Group
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 MilkingProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Cord Clamping at 30 Seconds (DCC-30) | Active comparator | The umbilical cord will be clamped between 1 - <60 seconds following delivery, with a goal of around 30 seconds. Receives: Procedure: Umbilical Cord Clamping at ~30 seconds |
| Delayed Cord Clamping at 120 Seconds (DCC-120) | Active comparator | 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. Receives: Procedure: Umbilical Cord Clamping at ~120 seconds; Procedure: Umbilical Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days post-discharge following congenital heart disease intervention
Secondary outcomes (20)
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.
Measured: 3-4 months after birth
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.
Measured: 3-4 months after birth
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.
Measured: 3-4 months after birth
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.
Measured: 9-12 months after birth
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) 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.
Measured: 9-12 months after birth
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.
Measured: 22-26 months after birth
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) 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.
Measured: 22-26 months after birth
Neurodevelopmental Outcomes at 22-26 months (Infant participant)
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.
Measured: 22-26 months after birth
Neurodevelopmental Outcomes at 22-26 months (Infant participant)
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.
Measured: 22-26 months after birth
Parental perspectives of outcomes (Parents / Caregivers)
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.
Measured: 22-26 months after birth
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of postpartum hemorrhage (defined as blood loss >1L within 24 hours post-delivery)
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of prolonged 3rd stage of labor (defined as retention of placenta for >30 minutes postpartum)
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of use of medications for postpartum hemorrhage management other than oxytocin (e.g., methergine, tranexamic acid, hemabate, misoprostol)
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of requirement for uterine balloon tamponade or other surgical intervention to treat postpartum hemorrhage
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of requirements for manual placental removal
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of requirement for transfusion, post-partum
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Volume of transfusion required, if applicable
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Type of transfusion required (e.g., whole blood, red blood cells, platelets, etc.), if applicable
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of postpartum endometritis
Measured: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Incidence of mortality
Measured: Through hospital discharge (up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start19 Dec 2023
- Primary completionOct 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Backes, MD
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Carl Backes, MD, Nationwide Children's Hospital
- Investigators
- Carl Backes, MD, Principal investigator, Nationwide Children's HospitalAnup Katheria, MD, Principal investigator, Sharp Mary Birch Hospital for Women & NewbornsKevin Hill, MD, Principal investigator, Duke Children's HospitalMadeline Rice, PhD, Principal investigator, George Washington University Biostatistics CenterGrecio (Greg) Sandoval, PhD, Principal investigator, George Washington University Biostatistics CenterScott Evans, PhD, Principal investigator, George Washington University Biostatistics Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153459
- Sponsor's protocol ID
- STUDY00003337
- Other IDs
- UG3HL166794, 5UH3HL166794, U24HL166799, UG3HL166799
- Acronym
- CORD-CHD
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available per NIH/NHLBI requirements (National Heart, Lung, and Blood Institute)
Publications
Marzec L, Zettler E, Cua CL, Rivera BK, Pasquali S, Katheria A, Backes CH. Timing of umbilical cord clamping among infants with congenital heart disease. Prog Pediatr Cardiol. 2020 Dec;59:101318. doi: 10.1016/j.ppedcard.2020.101318. Epub 2020 Oct 28.
PubMed 34113067Backes CH, Huang H, Cua CL, Garg V, Smith CV, Yin H, Galantowicz M, Bauer JA, Hoffman TM. Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial. J Perinatol. 2015 Oct;35(10):826-31. doi: 10.1038/jp.2015.89. Epub 2015 Jul 30.
PubMed 26226244Fite EL, Rivera BK, McNabb R, Smith CV, Hill KD, Katheria A, Maitre N, Backes CH. Umbilical cord clamping among infants with a prenatal diagnosis of congenital heart disease. Semin Perinatol. 2023 Jun;47(4):151747. doi: 10.1016/j.semperi.2023.151747. Epub 2023 Mar 18. No abstract available.
PubMed 37002126
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06153459
- Acronym / sponsor ID
- CORD-CHD / STUDY00003337
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- cord clamping, echocardiography (ECHO), congenital heart disease (CHD), CORD-CHD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Carl Backes, MDUniversity, hospital or other
- 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
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Cord Clamping at 30 Seconds (DCC-30) | Active comparator | Procedure: Umbilical Cord Clamping at ~30 secondsThe umbilical cord will be clamped between 1 - <60 seconds following delivery, with a goal of around 30 seconds. |
| Delayed Cord Clamping at 120 Seconds (DCC-120) | Active comparator | Procedure: Umbilical Cord Clamping at ~120 seconds, Procedure: Umbilical Cord MilkingThe 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. |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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 demise or planned termination of pregnancy prior to randomization
- Tachyarrhythmia requiring transplacental therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Clamping at ~30 secondsAlso: Randomized to DCC-30 GroupCare team will wait to clamp the umbilical between 1-<60 seconds after birth. 30 seconds is the ideal time of clamping. | Procedure or surgery | Delayed Cord Clamping at 30 Seconds (DCC-30) |
| Umbilical Cord Clamping at ~120 secondsAlso: Randomized to DCC-120 GroupCare team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping | Procedure or surgery | Delayed Cord Clamping at 120 Seconds (DCC-120) |
| Umbilical Cord MilkingFor 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. | Procedure or surgery | Delayed Cord Clamping at 120 Seconds (DCC-120) |
Primary outcome
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;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
20 secondary outcomes
Neuromotor Outcomes at 3-4 months of age (Infant participant)
Time frame: 3-4 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 3-4 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 3-4 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 9-12 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 9-12 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 22-26 months after birth
Impact of infant's congenital heart disease (Parents / Caregivers)
Time frame: 22-26 months after birth
Neurodevelopmental Outcomes at 22-26 months (Infant participant)
Time frame: 22-26 months after birth
Neurodevelopmental Outcomes at 22-26 months (Infant participant)
Time frame: 22-26 months after birth
Parental perspectives of outcomes (Parents / Caregivers)
Time frame: 22-26 months after birth
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Delivery Complications and Outcomes (Pregnant individual participant)
Time frame: Through hospital discharge (up to 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 34113067Marzec L, Zettler E, Cua CL, Rivera BK, Pasquali S, Katheria A, Backes CH. Timing of umbilical cord clamping among infants with congenital heart disease. Prog Pediatr Cardiol. 2020 Dec;59:101318. doi: 10.1016/j.ppedcard.2020.101318. Epub 2020 Oct 28.
- Background: PubMed 26226244Backes CH, Huang H, Cua CL, Garg V, Smith CV, Yin H, Galantowicz M, Bauer JA, Hoffman TM. Early versus delayed umbilical cord clamping in infants with congenital heart disease: a pilot, randomized, controlled trial. J Perinatol. 2015 Oct;35(10):826-31. doi: 10.1038/jp.2015.89. Epub 2015 Jul 30.
- Background: PubMed 37002126Fite EL, Rivera BK, McNabb R, Smith CV, Hill KD, Katheria A, Maitre N, Backes CH. Umbilical cord clamping among infants with a prenatal diagnosis of congenital heart disease. Semin Perinatol. 2023 Jun;47(4):151747. doi: 10.1016/j.semperi.2023.151747. Epub 2023 Mar 18. No abstract available.
- Individual participant dataSharing planned: Yes. Data will be made available per NIH/NHLBI requirements (National Heart, Lung, and Blood Institute)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carl Backes, MD principal investigator
Nationwide Children's Hospital
Anup Katheria, MD principal investigator
Sharp Mary Birch Hospital for Women & Newborns
Kevin Hill, MD principal investigator
Duke Children's Hospital
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Clamping at ~30 seconds, Umbilical Cord Clamping at ~120 seconds and Umbilical Cord Milking in people with Congenital Heart Disease (CHD), run by Carl Backes, MD at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Backes, MD (614-355-6729, carl.backes@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Rank Score (Infant participant) (time frame: Up to 30 days post-discharge following congenital heart disease intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153459, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.