Delayed Cord Clamping in Premature Infants

Anemia Clinical Trial

Official title:

Delayed Cord Clamping: Prevention of Anemia and Hypothermia in Premature Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01018576
• Other study ID #: 200916964
• Status: Terminated
• Phase: N/A
• First received: November 5, 2009
• Last updated: December 1, 2014
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: December 2014
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Minute

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Hypothermia

Intervention

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.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial body temperature		At birth	No
Secondary	Hematocrit at birth and 24 hours of age		first day of life	No