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Delayed Cord Clamping in Premature Infants

This study has been terminated.
(Inadequate numbers of babies enrolled and departure of co-investigator)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01018576
First Posted: November 23, 2009
Last Update Posted: December 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, Davis
November 5, 2009
November 23, 2009
December 2, 2014
September 2009
September 2011   (Final data collection date for primary outcome measure)
Initial body temperature [ Time Frame: At birth ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Terminated
6
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)
Sexes Eligible for Study: All
up to 1 Minute   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01018576
200916964
Yes
Not Provided
Not Provided
University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Mark A Underwood, MD UC Davis
University of California, Davis
December 2014

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