Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Women and Infants Hospital of Rhode Island
Brown University
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT00818220
First received: January 5, 2009
Last updated: December 9, 2013
Last verified: December 2013
  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 Neonatal Intensive Care Unit (NICU) and better motor skills at 7 months corrected age. The investigators will attempt to identify the mechanisms of effect through measurement of biologic markers.


Condition Intervention Phase
Intraventricular Hemorrhage
Sepsis
Procedure: delayed umbilical cord clamping
Other: Immediate cord clamping
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Protective Effects of Delayed Cord Clamping in VLBW Infants

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Very low birth weight (VLBW) infants in the delayed cord clamping (DCC) group will have less intraventricular hemorrhage (IVH) compared to VLBW infants in the immediate clamped (ICC) group [ Time Frame: December, 2012 ] [ Designated as safety issue: No ]
  • Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group [ Time Frame: December 2012 ] [ 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: November 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 212
Study Start Date: February 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1-Delayed Cord Clamping (DCC)
Immediately after birth, the infant is placed in a warm blanket and held lower than the placenta. The research nurse counts out 30 to 45 seconds for the obstetrician. The cord is milked once and then clamped at 30 to 45 seconds after birth.
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.
Other Names:
  • immediate cord clamping
  • cord milking
Active Comparator: 2-Immediate Cord Clamping (ICC)
Routine care which is immediate cord clamping
Other: Immediate cord clamping
The umbilical cord is cut within 10 seconds after birth
Other Name: routine care

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, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith S Mercer, Clinical Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT00818220     History of Changes
Other Study ID Numbers: 2980022, 5R01NR010015-02
Study First Received: January 5, 2009
Last Updated: December 9, 2013
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

Additional relevant MeSH terms:
Hemorrhage
Sepsis
Cerebral Hemorrhage
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014