1/2 cord-CHD: clamp or delay among neonates with congenital heart disease

Active Cooperative Agreement Awarded Last action

Award ID
UH3HL166794
Recipient
Awarding agency
Obligated
$6,481,896

Award facts

Assistance listing
93.837 Cardiovascular Diseases Research
Completion date 51% complete
Place of performance
Columbus, OH 43205, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Clamping and cutting the umbilical cord is the most common intervention in humans, occurring in 140 million annual births. To maximize expediency (manage 3RD stage of labor, initiate neonatal resuscitation), early cord clamping (ECC) is performed within ~30 SEC of delivery. Recently, evidence has emerged on the health benefits of delayed cord clamping (DCC, waiting ~1-2 min before clamping). Among term neonates, multiple randomized controlled trials (rcts) have shown that DCC transfers blood from placentas to newborns, resulting in less iron- deficiency anemia and improved neurodevelopmental (neuromotor) outcomes through 4 years, than with ECC. Despite advantages for healthy newborns, in view of their exclusion from previous rcts, the best approach to cord clamping in higher-risk pregnancies, notably those complicated by a fetal diagnosis of critical congenital heart disease (cchd), remains uncertain. Although one might assume that the benefits of DCC in low-risk new- born populations would translate simply to cchd neonates, unique anatomic and physiologic differences in neonates with cchd suggest that risks of DCC in this subgroup may differ from risks in neonates without cchd. Thus, a treatment dilemma exists on the optimal cord clamping practice at birth among cchd neonates. The proposed study, entitled cord-CHD (clamp or delay in neonates with congenital heart disease) trial will be the first RCT to determine the effectiveness of DCC VS. ECC on postnatal and neurodevelopmental outcomes of cchd neonates. Our preliminary data demonstrate that, among cchd neonates, DCC results in lower global rank scores (GRS), indicative of better health outcomes, than ECC. GRS is a validated composite measure, based upon the worst outcome post-cardiac surgery or catheterization and reflects the need for complex inten- sive care. Given the absence of high-quality data, maternal outcomes will also be determined. We will leverage a network of sites with requisite infrastructures, established guidelines with high adherence rates and treatment fidelity, and track records of collaboration. Aim 1 is to test the hypothesis that, among cchd neonates, DCC results in lower GRS (better outcomes) post-cardiac surgery or catheterization, based on a higher win-odds (win- ratio adapted to include ties), than with ECC. Aim 2 is to test the hypothesis that, among neonates with cchd, DCC will result in better neuromotor outcomes at 22-26MOS postnatal, based on a joint test of a bivariate outcome (developmental assessment of young children second edition motor score and the hammersmith neonate neurological exam) than with ECC. As a secondary objective, we will test the hypothesis that among cchd neonates improved neuromotor profiles (general movement assessment) at 3-4MOS mediate improved neuro- motor outcomes at 22-26MOS. Aim 3 is to precisely estimate the difference in the risk of maternal postpartum hemorrhage between DCC and ECC to evaluate safety among mothers who give birth to cchd neonates. This trial will advance the care of cchd neonates and provide the evidence called for by national and international organizations, creating a global impact on umbilical cord management among a vulnerable population.

Transactions

Action Obligated Date
Amendment $1,038,579
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Amendment $90,254
Amendment $90,254
Amendment $812,290
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Amendment $107,788
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Amendment $855,663
Amendment $855,663
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Original award $855,663
Show all 16

Subawards

Subrecipient Amount Awarded
The Medical University Of South Carolina 1/2 CORD-CHD: Clamp OR Delay among neonates with Congenital Heart Disease $30,800
Childrens Mercy Hospital $31,940
Regents Of The University Of Michigan Nationwide Children’s Hospital and the George Washington University are funded to conduct the CORD Clamping Among Neonates with Congenital Heart Disease… $50,642
Women & Infants Hospital Of Rhode Island This is a randomized trial to discern whether delayed cord clamping among infants with congenital heart disease improves neonatal outcome and does not worsen… $47,962
Sharp Mary Birch Hospital For Women And Newborns The CORD-CHD (Clamp OR Delay in Congenital Heart Disease) Trial, is a multi-center trial to determine whether Delayed Cord Clamping at 30 seconds (DCC-30) or… $130,764
The Children's Hospital Of Philadelphia Dr. Rychik is a Professor of Pediatrics at the University of Pennsylvania and a Pediatric Cardiologist and Director of the Fetal Heart Program at Children’s… $220,544
Duke University 1/2 CORD-CHD: Clamp OR Delay among neonates with Congenital Heart Disease $131,886
Emory University Dr. Maitre will secure two primary therapists within the CORD-CHD Neurodevelopmental Core. They will be certified examiners for all the neurodevelopmental… $425,694
The Ohio State University The primary objective of this randomized clinical trial is to test whether delayed cord clamping of ~120 seconds (DCC-120) vs. delayed cord clamping of ~30… $36,705

Quick answers

Who received award UH3HL166794?

UH3HL166794 was awarded to Research Institute At Nationwide Children's Hospital by National Heart Lung and Blood Institute (National Institutes of Health) on April 1, 2023.

How much is award UH3HL166794 worth?

$6,481,896 has been obligated on UH3HL166794.

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