Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Thrasher Research Fund
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT00840983
First received: February 10, 2009
Last updated: November 27, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Bronchopulmonary Dysplasia
Necrotizing Enterocolitis
Intraventricular Hemorrhage
Late Onset Neonatal Sepsis
Motor Skills Disorders
Procedure: delayed cord clamping
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group [ Time Frame: NICU stay ] [ Designated as safety issue: No ]
  • Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group. [ Time Frame: NICU Stay ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: August 2003
Study Completion Date: December 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1-Immediate Cord Clamping
infants received the routine care of immediate clamping of the umbilical cord
Experimental: 2-Delayed Cord Clamping
after birth, cord clamping was delayed 30 to 45 seconds while infant was held lower than the level of the placenta.
Procedure: delayed cord clamping
cord clamping was delayed for 30 to 45 seconds and infant was held lower than the level of the placenta
Other Name: cord clamping time

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00840983

Locations
United States, Rhode Island
Women & Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
University of Rhode Island
National Institute of Nursing Research (NINR)
Thrasher Research Fund
Investigators
Principal Investigator: Judith S Mercer, PhD, CNM University of Rhode Island
  More Information

Publications:
Responsible Party: Judith S Mercer, Professor Emerita, University of Rhode Island
ClinicalTrials.gov Identifier: NCT00840983     History of Changes
Other Study ID Numbers: Mercer-K23-03  R01NR010015-01A2 
Study First Received: February 10, 2009
Last Updated: November 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
delayed cord clamping
very low birthweight infant
bronchopulmonary dysplasia
intraventricular hemorrhage
motor function

Additional relevant MeSH terms:
Birth Weight
Hemorrhage
Enterocolitis, Necrotizing
Enterocolitis
Bronchopulmonary Dysplasia
Cerebral Hemorrhage
Motor Skills Disorders
Body Weight
Signs and Symptoms
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 22, 2016