Clinical Trial: Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Rhode Island

Current Primary Outcome:

  • 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 [ Time Frame: 36 wks postmenstrual 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 [ Time Frame: Hospital discharge ]
  • 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 [ Time Frame: 7 months corrected age ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group [ Time Frame: NICU stay ]
  • Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group. [ Time Frame: NICU Stay ]


Original Secondary Outcome: Same as current

Information By: University of Rhode Island

Dates:
Date Received: February 10, 2009
Date Started: August 2003
Date Completion:
Last Updated: November 27, 2015
Last Verified: November 2015