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A Cluster Randomized Clinical Trial of Umbilical Cord Milking to Improve Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth

Award Number: R01HD102967
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2021
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A Cluster Randomized Clinical Trial of Umbilical Cord Milking to Improve Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth - PROJECT SUMMARY At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. Worldwide each year, 10 million babies do not breathe immediately at birth, and approximately one million babies die annually in low and middle-income countries due to a brain injury caused by inadequate blood flow and oxygen delivery to the neonatal brain, a condition known as hypoxic ischemic encephalopathy (HIE). The usual practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. We propose a study to see if umbilical cord milking (UCM) for those infants who need resuscitation is better than immediately clamping and cutting the umbilical cord at birth. We wonder if it will reduce death and/or HIE. In addition, it may reduce developmental problems in survivors by two years of age. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies fromaround the world have identified that infants needing resuscitation are more likely to die or develop conditions such as cerebral palsy, autism and other developmental problems. The large amount of fetal blood left in the placenta after immediate cord clamping means that the baby gets less blood for the brain, lungs, and heart, which can contribute, to brain injury and even death. Cord milking at birth may help to protect these infants by increasing the transfer of blood volume. Our prior work has shown that, compared to immediate cord clamping, UCM results in better heart rate, blood pressure, less early anemia, and more oxygen in the brain. No harm from UCM has been noted in term infants in any studies. We will use a design in which each hospital will be randomly assigned to use either immediate cord clamping or UCM for any infant needing resuscitation over a period of 6 months. Then sites will change to the other method for an additional 6 months. This trial will involve 3442 term newborns who are depressed at birth at seven (7) hospitals in India. This trial will provide evidence to promote a change in guidelines supporting the use of UCM – a simple, no-cost intervention as standard of care in term and near-term newborns needing resuscitation.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	000	4	8/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $551,991 )
2024	2024	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	001	4	7/22/2024	NON-COMPETING CONTINUATION	$551,991
2024	2023	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	000	3	10/31/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $551,991

Issue Date FY: 2023 ( Subtotal = $557,364 )
2023	2023	THE NEMOURS FOUNDATION	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	001	3	8/14/2023	NON-COMPETING CONTINUATION	$557,364
2023	2022	NEMOURS FOUNDATION, THE	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	000	2	1/25/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $557,364

Issue Date FY: 2022 ( Subtotal = $556,130 )
2022	2022	NEMOURS FOUNDATION, THE	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	001	2	8/9/2022	NON-COMPETING CONTINUATION	$556,130
2022	2021	NEMOURS FOUNDATION, THE	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	000	1	10/14/2021	NEW	$0
														Subtotal = $556,130

Issue Date FY: 2021 ( Subtotal = $587,446 )
2021	2021	NEMOURS FOUNDATION, THE	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	000	1	7/30/2021	NEW	$587,446
2021	2021	NEMOURS FOUNDATION, THE	1600 ROCKLAND RD	WILMINGTON	DE	19803	NEW CASTLE	USA	Child Health and Human Development Extramural Research	001	1	9/22/2021	NEW	$0
														Subtotal = $587,446

Grand Total All Awards = $2,252,931

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A Cluster Randomized Clinical Trial of Umbilical Cord Milking to Improve Short and Long-term Outcomes in Neonates Who are Non-Vigorous at Birth

Award Number: R01HD102967

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2021

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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