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Completed

NCT Number: NCT00818220

Protective Effects of Delayed Cord Clamping in Very Low Birth Weight (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 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed umbilical cord clamping

Procedure

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

Immediate cord clamping

Other

The umbilical cord is cut within 10 seconds after birth

Other names: routine care

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. VLBW infants in the DCC group will have better motor function at 7 months corrected age

    Time frame: November 2012

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • Brown University
  • National Institute of Nursing Research (NINR)
  • Women and Infants Hospital of Rhode Island

Registry information

Official study title

Protective Effects of Delayed Cord Clamping in VLBW Infants

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jan 7, 2009
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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