Cord Clamping Among Neonates With Congenital Heart Disease
NCT ID: NCT06153459
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2023-12-19
2030-12-31
Brief Summary
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* 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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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
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.
Interventions
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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.
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
For each potential participant that has provided consent, the most relevant diagnostic prenatal ultrasound will be uploaded (shared) between 32 weeks of gestation and randomization for review by the ECHO Core. The ECHO Core will make the final FCDSS determination for eligibility status and stratification assignment.\]
\[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\]
2. Singleton gestation.
3. 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.
\[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window". Alternatively, if an eligible dyad is randomized at or just prior to 41 6/7 weeks, they remain in trial.\]
4. Consent for the participant and their infant
Exclusion Criteria
2. 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
\[NOTE: There is no limitation on pregnant individual's age\]
1. Fetal demise or planned termination of pregnancy prior to randomization
2. Tachyarrhythmia requiring transplacental therapy
3. Fetal hydrops, severe
4. Planned fetal surgery
5. Diaphragmatic hernia, omphalocele, gastroschisis, intestinal atresia
6. Major chromosomal defects (e.g., Trisomy 13, 18) identified prenatally; Trisomy 21 is allowed
7. Disease or disorder impacting candidacy for neonatal cardiac interventions
8. Parents choosing to limit treatment
1. Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating site
2. Participation in another prenatal interventional study that influences cord clamping or perinatal morbidity or mortality
37 Weeks
42 Weeks
ALL
No
Sponsors
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The George Washington University Biostatistics Center
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Emory University
OTHER
Boston Children's Hospital
OTHER
University of Bristol
OTHER
Geisinger Commonwealth School of Medicine
UNKNOWN
Duke University
OTHER
Children's Hospital of Philadelphia
OTHER
Sharp Mary Birch Hospital for Women & Newborns
OTHER
Université de Montréal
OTHER
Carl Backes, MD
OTHER
Responsible Party
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Carl Backes, MD
Principal Investigator
Principal Investigators
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Carl Backes, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Anup Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp Mary Birch Hospital for Women & Newborns
Kevin Hill, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Children's Hospital
Madeline Rice, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Grecio (Greg) Sandoval, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Scott Evans, PhD
Role: PRINCIPAL_INVESTIGATOR
George Washington University Biostatistics Center
Locations
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Children's of Alabama
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
Sharp Mary Birch Hospital for Woman and Newborns
San Diego, California, United States
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
Children's of Mississippi
Jackson, Mississippi, United States
The Children's Mercy Hospital
Kansas City, Missouri, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Columbia, South Carolina, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Backes 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.
Fite 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.
Other Identifiers
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UG3HL166799
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00003337
Identifier Type: -
Identifier Source: org_study_id
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