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

Phase 2

Completed

• Conditions: Intraventricular Hemorrhage; Sepsis
• Interventions: Other: Immediate cord clamping; Procedure: delayed umbilical cord clamping

• Registration Number: NCT00818220
• Lead Sponsor: University of Rhode Island

Brief Summary

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.

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-06
• Study First Posted: 2009-01-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Immediate Cord Clamping (ICC)	Immediate cord clamping	Routine care which is immediate cord clamping
1-Delayed Cord Clamping (DCC)	delayed umbilical cord clamping	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.

Primary Outcome Measures

Name	Time	Method
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	December, 2012
Very low birth weight infants in the delayed cord clamping group will have less late onset sepsis than those in the immediate clamping group	December 2012

Secondary Outcome Measures

Name	Time	Method
VLBW infants in the DCC group will have better motor function at 7 months corrected age	November 2012

Trial Locations

Locations (1)

Women and Infants Hospital; 🇺🇸 Providence, Rhode Island, United States