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Sponsors and Collaborators: |
University of Rhode Island Women and Infants Hospital of Rhode Island Brown University |
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Information provided by: | University of Rhode Island |
ClinicalTrials.gov Identifier: | NCT00818220 |
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. We will attempt to identify the mechanisms of effect through measurement of biologic markers.
Condition | Intervention | Phase |
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Intraventricular Hemorrhage Late Onset Sepsis |
Procedure: delayed umbilical cord clamping |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Protective Effects of Delayed Cord Clamping in VLBW Infants |
Estimated Enrollment: | 212 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: 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.
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Procedure: delayed umbilical cord clamping
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.
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2: No Intervention
Routine care which is immediate cord clamping
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judith S Mercer, PhD, CNM | 401-274-1122 ext 1795 | jmercer@uri.edu |
United States, Rhode Island | |
Women and Infants Hospital | Recruiting |
Providence, Rhode Island, United States, 02905 | |
Contact: Mercer 401-274-1122 ext 1795 | |
Sub-Investigator: James Padbury, MD |
Principal Investigator: | Judith S Mercer, PhD, CNM | University of Rhode Island, Brown University |
Responsible Party: | University of Rhode Island ( Judith S Mercer, PhD, CNM, Prinicipal Investigator ) |
Study ID Numbers: | 2980022, RO1-NR010015 |
Study First Received: | January 5, 2009 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00818220 |
Health Authority: | United States: Institutional Review Board |
intraventricular hemorrhage sepsis motor function |
motor functioning at 7 months corrected age cytokines in cord blood and at 6 and 20 hours of age stem cells in cord blood and at 20 hours of age |
Systemic Inflammatory Response Syndrome Body Weight Birth Weight Cerebral Hemorrhage Sepsis Vascular Diseases |
Central Nervous System Diseases Intracranial Hemorrhages Brain Diseases Hemorrhage Cerebrovascular Disorders Inflammation |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases Infection |