Effects of Delayed Cord Clamping in Very Low Birth Weight Infants
NCT ID: NCT00840983
Last Updated: 2015-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2003-08-31
2006-12-31
Brief Summary
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Detailed Description
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The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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1-Immediate Cord Clamping
infants received the routine care of immediate clamping of the umbilical cord
No interventions assigned to this group
2-Delayed Cord Clamping
after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.
delayed cord clamping
cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
Interventions
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delayed cord clamping
cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Obstetrician's approval of enrollment into study
* Parental consent
* Any mode of birth will be included
Exclusion Criteria
* Parental refusal for consent
* Prenatally-diagnosed major congenital anomalies \[or multiple gestations\]
* Intent to withhold or withdraw care
* Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
* Mothers who are institutionalized or psychotic
FEMALE
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Thrasher Research Fund
OTHER
University of Rhode Island
OTHER
Responsible Party
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Judith S Mercer
Professor Emerita
Principal Investigators
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Judith S Mercer, PhD, CNM
Role: PRINCIPAL_INVESTIGATOR
University of Rhode Island
Locations
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Women & Infants Hospital
Providence, Rhode Island, United States
Countries
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References
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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.
Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22.
Mercer 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.
Other Identifiers
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Mercer-K23-03
Identifier Type: -
Identifier Source: org_study_id