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Delayed Cord Clamping in Premature Infants

NCT ID: NCT01018576

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Hypothermia Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Delayed cord clamping

Group Type EXPERIMENTAL

Delayed cord clamping

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark A Underwood, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200916964

Identifier Type: -

Identifier Source: org_study_id