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 |
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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
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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
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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. |
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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
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Both |
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No |
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United States |
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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
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Principal Investigator: |
Judith S Mercer, PhD, CNM |
University of Rhode Island, Brown University |
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University of Rhode Island |
February 2009 |