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
  Purpose

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 Intervention
Hypothermia
Anemia
Other: Delayed cord clamping

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Initial body temperature [ Time Frame: At birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hematocrit at birth and 24 hours of age [ Time Frame: first day of life ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Minute
Genders Eligible for Study:   Both
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)
  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: NCT01018576

Contacts
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

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

No publications provided

Responsible Party: Mark Underwood MD, UC Davis, Department of Pediatrics
ClinicalTrials.gov Identifier: NCT01018576     History of Changes
Other Study ID Numbers: 200916964
Study First Received: November 5, 2009
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

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
Hypothermia
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014