Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

University of Rhode Island

Status and phase: Completed; Phase 1

Conditions: Intraventricular Hemorrhage; Necrotizing Enterocolitis; Late Onset Neonatal Sepsis; Bronchopulmonary Dysplasia; Motor Skills Disorders

Treatments: Procedure: delayed cord clamping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00840983

R01NR010015-01A2 (U.S. NIH Grant/Contract)

Mercer-K23-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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72 participants in 2 patient groups

1-Immediate Cord Clamping

No Intervention group

Description:

infants received the routine care of immediate clamping of the umbilical cord

2-Delayed Cord Clamping

Experimental group

Description:

after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.

Treatment:

Procedure: delayed cord clamping