Delayed Cord Clamping in Premature Infants
Primary Purpose
Hypothermia, Anemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Delayed cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants
Eligibility 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)
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Delayed cord clamping
Arm Description
Outcomes
Primary Outcome Measures
Initial body temperature
Secondary Outcome Measures
Hematocrit at birth and 24 hours of age
Full Information
NCT ID
NCT01018576
First Posted
November 5, 2009
Last Updated
December 1, 2014
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01018576
Brief Title
Delayed Cord Clamping in Premature Infants
Official Title
Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Inadequate numbers of babies enrolled and departure of co-investigator
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Anemia
Keywords
delayed cord clamping, premature infants, hypothermia, anemia, intraventricular hemorrhage, Anemia in premature infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed cord clamping
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Delayed cord clamping
Intervention Description
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 Measure Information:
Title
Initial body temperature
Time Frame
At birth
Secondary Outcome Measure Information:
Title
Hematocrit at birth and 24 hours of age
Time Frame
first day of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Minute
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Underwood, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Delayed Cord Clamping in Premature Infants
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