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Delayed Cord Clamping in Premature Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01018576
First received: November 5, 2009
Last updated: March 14, 2011
Last verified: March 2011

November 5, 2009
March 14, 2011
September 2009
September 2011   (final data collection date for primary outcome measure)
Initial body temperature [ Time Frame: At birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018576 on ClinicalTrials.gov Archive Site
Hematocrit at birth and 24 hours of age [ Time Frame: first day of life ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Delayed Cord Clamping in Premature Infants
Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Delayed cord clamping has been shown to decrease the risk of bleeding in the brain of premature infants. However this procedure is not standard due to concerns that the premature infant will get too cold. In this study the investigators look at using a plastic covering and a chemical warmer to keep the small premature baby warm while waiting 30-60 seconds to clamp the umbilical cord.

Enrolled premature infants will be compared to age matched historical controls that did not receive delayed cord clamping but were placed under a warmer immediately after birth. Outcomes to be analyzed include initial body temperature, hematocrit at birth and 24 hours of age, number of red blood cell transfusions during hospital stay, umbilical cord gas, first blood gas following delivery, blood pressure data in the first 24 hours, fluid bolus and inotrope requirement in the first 24 hours, incidence of intraventricular hemorrhage and late-onset sepsis, peak bilirubin level, length of phototherapy, and Apgar scores.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Hypothermia
  • Anemia
Other: Delayed cord clamping
Infants will be covered with plastic and placed on a chemical warmer at delivery and then clamping of the umbilical cord will be delayed for 30-60 seconds.
Experimental: Delayed cord clamping
Intervention: Other: Delayed cord clamping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
March 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • premature infants at 24-28 completed weeks gestation at the time of delivery
  • informed consent obtained from parents prior to delivery

Exclusion Criteria:

  • multiple gestation (twins, triplets, etc)
  • prolonged fetal bradycardia
  • placental abruption or previa
  • maternal illness
  • major congenital anomalies
  • maternal fever in labor
  • fetal illness (e.g. isoimmune hemolysis)
Both
up to 1 Minute
No
Contact: Anthony Wartell, MD 916-703-3050 anthony.wartell@ucdmc.ucdavis.edu
Contact: Mark A Underwood, MD 916-762-7892 mark.underwood@ucdmc.ucdavis.edu
United States
 
NCT01018576
200916964
Yes
Mark Underwood MD, UC Davis, Department of Pediatrics
University of California, Davis
Not Provided
Principal Investigator: Mark A Underwood, MD UC Davis
University of California, Davis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP