Delayed Cord Clamping 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.
|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|
- Initial body temperature [ Time Frame: At birth ] [ Designated as safety issue: No ]
- Hematocrit at birth and 24 hours of age [ Time Frame: first day of life ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018576
|United States, California|
|UC Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Mark A Underwood, MD||UC Davis|