Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
2 other identifiers
interventional
211
1 country
1
Brief Summary
The purpose of this study is to determine whether the intervention of delaying cord clamping for 30 to 45 seconds followed by one milking of the cord while simultaneously lowering the VLBW infants below the introitus will result in less bleeding in the brain and fewer infections while in the Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 27, 2015
May 1, 2015
6.1 years
January 5, 2009
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group
December, 2012
Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group
December 2012
Secondary Outcomes (1)
VLBW infants in the DCC group will have better motor function at 7 months corrected age
November 2012
Study Arms (2)
1-Delayed Cord Clamping (DCC)
EXPERIMENTALImmediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth.
2-Immediate Cord Clamping (ICC)
ACTIVE COMPARATORRoutine care which is immediate cord clamping
Interventions
at birth, the clamping of the umbilical cord will be delayed 30 to 45 seconds while the child is held lower than the placenta. At the end of the time, the cord is milked once and the cord is clamped. If the obstetrician feels he cannot delay the cord clamping, then the cord can be milked 2 to 3 times.
The umbilical cord is cut within 10 seconds after birth
Eligibility Criteria
You may qualify if:
- Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
- Vaginal or cesarean birth
You may not qualify if:
- Congenital anomaly
- Multiple gestation
- Intent to withhold or withdraw care
- Severe or multiple maternal illnesses
- Mothers who are institutionalized or psychotic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rhode Islandlead
- Women and Infants Hospital of Rhode Islandcollaborator
- Brown Universitycollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
Related Publications (4)
Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. doi: 10.1542/peds.2005-1706.
PMID: 16585320BACKGROUNDWang M, Mercer JS, Padbury JF. Delayed Cord Clamping in Infants with Suspected Intrauterine Growth Restriction. J Pediatr. 2018 Oct;201:264-268. doi: 10.1016/j.jpeds.2018.05.028. Epub 2018 Jun 25.
PMID: 29954605DERIVEDMercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.2015.09.068. Epub 2015 Nov 4.
PMID: 26547399DERIVEDSommers R, Stonestreet BS, Oh W, Laptook A, Yanowitz TD, Raker C, Mercer J. Hemodynamic effects of delayed cord clamping in premature infants. Pediatrics. 2012 Mar;129(3):e667-72. doi: 10.1542/peds.2011-2550. Epub 2012 Feb 13.
PMID: 22331336DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Judith S Mercer, PhD, CNM
University of Rhode Island, Brown University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 7, 2009
Study Start
February 1, 2008
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 27, 2015
Record last verified: 2015-05