Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Phase 1

Completed

• Conditions: Bronchopulmonary Dysplasia; Late Onset Neonatal Sepsis; Necrotizing Enterocolitis; Intraventricular Hemorrhage; Motor Skills Disorders
• Interventions: Procedure: delayed cord clamping

• Registration Number: NCT00840983
• Lead Sponsor: University of Rhode Island

Brief Summary

The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.

Detailed Description

When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.

The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2005-11
• Study Completion: 2006-12
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
• Obstetrician's approval of enrollment into study
• Parental consent
• Any mode of birth will be included

Exclusion Criteria

• Obstetrician's refusal to enroll infants
• Parental refusal for consent
• Prenatally-diagnosed major congenital anomalies [or multiple gestations]
• Intent to withhold or withdraw care
• Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
• Mothers who are institutionalized or psychotic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2-Delayed Cord Clamping	delayed cord clamping	after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.

Primary Outcome Measures

Name	Time	Method
VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped	36 wks postmenstrual age
VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group	7 months corrected age
VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group	Hospital discharge

Secondary Outcome Measures

Name	Time	Method
Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group	NICU stay
Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.	NICU Stay

Trial Locations

Locations (1)

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