Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00840983
• Other study ID #: Mercer-K23-03
• Secondary ID: R01NR010015-01A2
• Status: Completed
• Phase: Phase 1
• First received: February 10, 2009
• Last updated: November 27, 2015
• Start date: August 2003
• Est. completion date: December 2006

Study information

• Verified date: November 2015
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Cerebral Hemorrhage
• Enterocolitis
• Enterocolitis, Necrotizing
• Hemorrhage
• Intraventricular Hemorrhage
• Late Onset Neonatal Sepsis
• Motor Skills Disorders
• Necrotizing Enterocolitis

Intervention

Procedure:
• delayed cord clamping
cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
University of Rhode Island	National Institute of Nursing Research (NINR), Thrasher Research Fund

Country where clinical trial is conducted

United States, 

References & Publications (3)

Mercer JS, Erickson-Owens DA, Vohr BR, Tucker RJ, Parker AB, Oh W, Padbury JF. Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jan;168:50-55.e1. doi: 10.1016/j.jpeds.201 — View Citation

Mercer JS, Vohr BR, Erickson-Owens DA, Padbury JF, Oh W. Seven-month developmental outcomes of very low birth weight infants enrolled in a randomized controlled trial of delayed versus immediate cord clamping. J Perinatol. 2010 Jan;30(1):11-6. doi: 10.1038/jp.2009.170. Epub 2009 Oct 22. — View Citation

Mercer JS, Vohr BR, McGrath MM, Padbury JF, Wallach M, Oh W. Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):1235-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group		NICU stay	No
Secondary	Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.		NICU Stay	No