Delayed Cord Clamping in Premature Infants

Not Applicable

Terminated

• Conditions: Hypothermia; Anemia
• Interventions: Other: Delayed cord clamping

• Registration Number: NCT01018576
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-23
• Primary Completion: 2011-09
• Study Completion: 2012-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Delayed cord clamping	Delayed cord clamping	-

Primary Outcome Measures

Name	Time	Method
Initial body temperature	At birth

Secondary Outcome Measures

Name	Time	Method
Hematocrit at birth and 24 hours of age	first day of life

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States