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Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
This study is currently recruiting participants.
Verified by University of Rhode Island, August 2008
Sponsors and Collaborators: University of Rhode Island
Women and Infants Hospital of Rhode Island
Brown University
Information provided by: University of Rhode Island
ClinicalTrials.gov Identifier: NCT00818220
  Purpose

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
Intraventricular Hemorrhage
Late Onset Sepsis
Procedure: delayed umbilical cord clamping
Phase II

MedlinePlus related topics: Sepsis
U.S. FDA Resources
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

Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • VLBW infants in the DCC group will have less IVH compared to VLBW infants in the ICC group [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VLBW infants in the DCC group will have better motor function at 7 months corrected age [ Time Frame: End of study ] [ Designated as safety issue: No ]

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
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.
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.
2: No Intervention
Routine care which is immediate cord clamping

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818220

Contacts
Contact: Judith S Mercer, PhD, CNM 401-274-1122 ext 1795 jmercer@uri.edu

Locations
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            
Sponsors and Collaborators
University of Rhode Island
Women and Infants Hospital of Rhode Island
Brown University
Investigators
Principal Investigator: Judith S Mercer, PhD, CNM University of Rhode Island, Brown University
  More Information

Publications:
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

Keywords provided by University of Rhode Island:
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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009