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Trial record 12 of 48 for:    necrotizing enterocolitis | NIH

Effects of Delayed Cord Clamping in Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00840983
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : November 30, 2015
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Thrasher Research Fund
Information provided by (Responsible Party):
Judith S Mercer, University of Rhode Island

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
Study Start Date : August 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
Other 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 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Hemorrhage
Birth Weight
Bronchopulmonary Dysplasia
Neonatal Sepsis
Cerebral Hemorrhage
Motor Skills Disorders
Pathologic Processes
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases