Skip to main content
OpenTrials
Completed

NCT Number: NCT00840983

Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Infections Inflammation Intestinal Diseases Intraventricular Hemorrhage Late Onset Neonatal Sepsis Lung Diseases Lung Injury Mental Disorders Motor Skills Disorders Necrotizing Enterocolitis Neonatal Sepsis Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Ventilator-Induced Lung Injury

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed Cord Clamping

Procedure

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

Other names: cord clamping time

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group

    Time frame: NICU stay

  2. Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.

    Time frame: NICU Stay

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Thrasher Research Fund

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Feb 11, 2009
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.