Trial of Immediate vs. Delayed Cord Clamping in the Preterm Neonate

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2011-05-31

Brief Summary

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To determine the short and long term effects of placental transfusion at birth by milking and delayed cord clamping of the umbilical cord in neonates born between 24 weeks 0 days and 34 weeks 0 days weeks' gestation.

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Detailed Description

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This study is intended to be a randomized controlled trial comparing immediate cord clamping which represents the current standard of care at Oklahoma University Medical Center with delayed cord clamping among preterm neonates born between 24 weeks and 34 weeks 0 days weeks' gestation. Allocation sequence will be generated by simple randomization using random number table in the stratum 24-28 weeks 6 days and 29 weeks to 34 weeks 0 days weeks' gestation stratum.

Conditions

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PreTerm Birth PreTerm Neonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Delayed Cord Clamping

Group Type EXPERIMENTAL

Delayed Cord Clamping

Intervention Type PROCEDURE

Delayed Cord Clamping: 30-35 seconds after birth

B

Immediate cord clamping

Group Type ACTIVE_COMPARATOR

Immediate Cord Clamping

Intervention Type PROCEDURE

Immediate Cord Clamping: within 5 seconds of birth

Interventions

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Delayed Cord Clamping

Delayed Cord Clamping: 30-35 seconds after birth

Intervention Type PROCEDURE

Immediate Cord Clamping

Immediate Cord Clamping: within 5 seconds of birth

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancies
* Signed consent to participate in the trial

Exclusion Criteria

* Major fetal anomaly or known fetal chromosomal abnormalities
* Multiple gestation
* Mothers with pregestational and gestational diabetes
* Refusal to participate in the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes