Comparing Umbilical Cord Clamping at ~30 seconds with Umbilical Cord Clamping at ~120 seconds for congenital heart disease (CHD)
Official title: Cord Clamping Among Neonates With Congenital Heart Disease
CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
- 2 groups
- Sites in Edmonton, Halifax and 1 more city
- Recruiting
Interventions
- Medical 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.
- Medical 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
- Medical 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.
Canadian Sites (3)
2 of 3 recruiting
- Recruiting
Stollery Children's Hospital, University of Alberta
Edmonton, Alberta
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
- Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. 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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → for randomization).
- +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.
- +are listed below and will be confirmed prior to randomization:
- +For each potential participant that has provided consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, 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 stratificationStratificationSplitting participants into subgroups first, so groups stay balanced.Read more → assignment.\]
- +Singleton gestation.
- +Consent for the participant and their infant
- +Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are listed below and will be confirmed prior to randomization:
- +\[NOTE: Pregnant individuals who were admitted to the delivery hospital prior to 37 0/7 weeks of gestation remain eligible to randomize, provided they deliver within the 37 0/7 and 41 6/7 weeks "eligibility window". Alternatively, if an eligible dyad is randomized at or just prior to 41 6/7 weeks, they remain in trial.\]
- +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
- +\[NOTE: There is no limitation on pregnant individual's age\]
- +\[NOTE: A fetal diagnosis of CHD rated as 3 - 6 FCDSS per local review, including borderline cases, will be used to determine preliminary eligibility for consent. Among borderline cases, eligible patients will be included if there is a reasonable expectation of the need for surgery or cardiac catheterization during the birth hospitalization.\]
Exclusion
- −are listed below and will be confirmed prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →:
- −Fetal Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −Tachyarrhythmia requiring transplacental therapy
- −Fetal hydrops, severe
- −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
- −Delivery planned at an institution not affiliated with or does not refer to a CORD-CHD participating siteTrial siteA hospital or clinic where a study is actually run.Read more →
- −Participation in another prenatal interventional studyInterventional studyA study where participants are given something to see what happens.Read more → that influences cord clamping or perinatal morbidity or mortality
- −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 demise or planned termination of pregnancy prior to randomization
- −Pregnancy Exclusion Criteria:
- −Planned fetal surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Umbilical Cord Clamping at ~30 seconds.
Registry label: A: Delayed Cord Clamping at 30 Seconds (DCC-30)
Group B, the comparison group, receives one or more of: Umbilical Cord Clamping at ~120 seconds and Umbilical Cord Milking.
Registry label: B: Delayed Cord Clamping at 120 Seconds (DCC-120)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 37 weeks to 42 weeks.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 500 people.
The study is currently expected to finish around December 2030.
The main measurement is taken over: Up to 30 days post-discharge following congenital heart disease intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Global Rank Score (Infant participant) — measured over Up to 30 days post-discharge following congenital heart disease intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06153459 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Umbilical Cord Clamping at ~30 secondsProcedure
Care team will wait to clamp the umbilical between 1-\<60 seconds after birth. 30 seconds is the ideal time of clamping.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Umbilical Cord Clamping at ~120 secondsProcedure
Care team will wait to clamp the umbilical cord between 60-180 seconds after birth.120 seconds is the ideal time of clamping
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Umbilical Cord MilkingProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 37 weeks to 42 weeks.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 37 weeks to 42 weeks.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 30 days post-discharge following congenital heart disease intervention.
The study as a whole is currently expected to finish around 2030-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 500 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Edmonton, Alberta, Canada; Halifax, Nova Scotia, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.