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Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
This study is currently recruiting participants.
Study NCT00818220   Information provided by University of Rhode Island
First Received: January 5, 2009   Last Updated: February 12, 2009   History of Changes
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January 5, 2009
February 12, 2009
February 2008
VLBW infants in the DCC group will have less IVH compared to VLBW infants in the ICC group [ Time Frame: December, 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00818220 on ClinicalTrials.gov Archive Site
VLBW infants in the DCC group will have better motor function at 7 months corrected age [ Time Frame: November 2012 ] [ Designated as safety issue: No ]
Same as current
 
Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
Protective Effects of Delayed Cord Clamping in VLBW Infants

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 NICU and better motor skills at 7 months of age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.

The current obstetrical practice at birth in the United States is that the umbilical cord of the very low birth weight (VLBW) infant is clamped immediately. When immediate cord clamping occurs, up to 25% of the fetal-placental blood volume may be left in the placenta acutely increasing vulnerability to hypovolemia. Hypovolemia can precipitate a cascade of physiologic events including poor tissue perfusion, ischemia, and initiation of the fetal/neonatal inflammatory response. Intraventricular hemorrhage (IVH) is a major cause of brain injury for preterm infants and is a predictor of poor neurodevelopment outcomes. Late onset sepsis (LOS) is also associated with morbidity and mortality in the NICU and later developmental delay. Of the approximately 57,000 infants born annually at less than 1500 grams, 10% develop cerebral palsy and 25 to 50% show later cognitive and behavioral deficits affecting school performance with higher rates found in males. We propose a trial with a sample of 212 randomized infants to validate our prior findings that delaying the cord clamping lowers the incidence of intraventricular hemorrhage and late onset sepsis, and to identify the mechanisms of effect through the study of biologic markers including measurement of cytokines (IL-6 and VEGF), circulating stem cells, and red cell volume. Enrolled women in preterm labor will be randomized at birth to the immediate cord clamping group or the delayed clamping group. Assessment of motor outcomes is planned at 7 months corrected age. This study will help to establish a scientific basis for the timing of cord clamping of VLBW infants. The innovation of this study is in the simplicity of delaying cord clamping for 30 to 45 seconds and lowering the VLBW infants at birth. This low-tech change in a clinical practice has the potential to reduce the risk of disease and disability and to improve the neonatal and early childhood outcomes for these most vulnerable preterm infants.

Phase II
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Intraventricular Hemorrhage
  • Late Onset Sepsis
Procedure: delayed umbilical cord clamping
  • Experimental: The umbilical cord will be clamped at 30 to 45 seconds after birth and after one milking of the cord while infant is held lower than the introitus.
  • No Intervention: Routine care which is immediate cord clamping
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
212
January 2013
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant women between 24 and 31.6 weeks gestation at risk of delivery
  • Vaginal or cesarean birth

Exclusion Criteria:

  • Congenital anomaly
  • Multiple gestation
  • Intent to withhold or withdraw care
  • Severe or multiple maternal illnesses
  • Mothers who are institutionalized or psychotic
Both
 
No
Contact: Judith S Mercer, PhD, CNM 401-274-1122 ext 1795 jmercer@uri.edu
United States
 
 
NCT00818220
Judith S Mercer, PhD, CNM, Prinicipal Investigator, University of Rhode Island
RO1-NR010015
University of Rhode Island
  • Women and Infants Hospital of Rhode Island
  • Brown University
Principal Investigator: Judith S Mercer, PhD, CNM University of Rhode Island, Brown University
University of Rhode Island
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.