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Delayed Cord Clamping in Premature Infants

University of California (UC) Davis logo

University of California (UC) Davis

Status

Terminated

Conditions

Anemia
Hypothermia

Treatments

Other: Delayed cord clamping

Study type

Interventional

Funder types

Other

Identifiers

NCT01018576
200916964

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

Under 1 minute old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

Delayed cord clamping
Experimental group
Treatment:
Other: Delayed cord clamping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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