CORD-CHD: Clamp OR Delay Among Neonates With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 42
- 主要终点
- Global Rank Score (Infant participant)
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are listed below and will be confirmed prior to randomization:
- •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).
- •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.]
- •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.
- •[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.]
- •Consent for the participant and their infant
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Umbilical Cord Milking (Procedure)
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.
干预措施: Umbilical Cord Clamping at ~30 seconds (Procedure)
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.
干预措施: Umbilical Cord Clamping at ~120 seconds (Procedure)
结局指标
主要结局
Global Rank Score (Infant participant)
时间窗: 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
Global Rank Score (Infant participant)
时间窗: 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
次要结局
- Neuromotor Outcomes at 3-4 months of age (Infant participant)(3-4 months after birth)
- Parental perspectives of outcomes (Parents / Caregivers)(22-26 months after birth)
- Impact of infant's congenital heart disease (Parents / Caregivers)(22-26 months after birth)
- Neurodevelopmental Outcomes at 22-26 months (Infant participant)(22-26 months after birth)
- Delivery Complications and Outcomes (Pregnant individual participant)(Through hospital discharge (up to 1 month))
研究者
Carl Backes, MD
Principal Investigator
Nationwide Children's Hospital