Delayed Cord Clamping in Premature Infants
Recruitment status was Recruiting
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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 |
- 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 ]
| 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 |
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| 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 |
| United States, California | |
| UC Davis Medical Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: Mark A Underwood, MD | |
| 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 May 19, 2013