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Delayed Cord Clamping in Premature Infants

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ClinicalTrials.gov Identifier: NCT01018576
Recruitment Status : Terminated (Inadequate numbers of babies enrolled and departure of co-investigator)
First Posted : November 23, 2009
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypothermia Anemia Other: Delayed cord clamping Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Hypothermia

Arm Intervention/treatment
Experimental: Delayed cord clamping 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.




Primary Outcome Measures :
  1. Initial body temperature [ Time Frame: At birth ]

Secondary Outcome Measures :
  1. Hematocrit at birth and 24 hours of age [ Time Frame: first day of life ]


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Ages Eligible for Study:   up to 1 Minute   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT01018576


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Mark A Underwood, MD UC Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01018576     History of Changes
Other Study ID Numbers: 200916964
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by University of California, Davis:
delayed cord clamping
premature infants
hypothermia
anemia
intraventricular hemorrhage
Anemia in premature infants

Additional relevant MeSH terms:
Anemia
Premature Birth
Hypothermia
Hematologic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Body Temperature Changes
Signs and Symptoms