Delayed Cord Clamping in VLBW Infants

NCT ID: NCT01222364

Last Updated: 2017-09-26

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

PHASE1/PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2000-12-31

Brief Summary

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This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.

Detailed Description

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This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.

This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.

Conditions

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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Cord Clamping

Group Type ACTIVE_COMPARATOR

Standard Cord Clamping

Intervention Type PROCEDURE

Immediate clamping (\<5 seconds) of the umbilical cord after delivery.

Delayed Cord Clamping

Group Type EXPERIMENTAL

Delayed Cord Clamping

Intervention Type PROCEDURE

Clamping of the umbilical cord at 30-45 seconds after birth.

Interventions

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Standard Cord Clamping

Immediate clamping (\<5 seconds) of the umbilical cord after delivery.

Intervention Type PROCEDURE

Delayed Cord Clamping

Clamping of the umbilical cord at 30-45 seconds after birth.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infants born at participating centers at 24-27 weeks gestation
* Singletons
* Obstetrician approval for enrollment
* Parental consent

Exclusion Criteria

* Prenatally diagnosed major congenital anomalies
* Intent to withhold or withdraw care
* Significant bleeding due to placenta previa or abruption
Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

NICHD Neonatal Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Brown University, Women & Infants Hospital of Rhode Island

Principal Investigators

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William Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Avroy A. Fanaroff, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Rainbow Babies and Children's Hospital

Edward F. Donovan, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

Countries

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United States

Related Links

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http://neonatal.rti.org/

NICHD Neonatal Research Network

Other Identifiers

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U10HD021364

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01HD021438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10HD027904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M01RR000080

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M01RR008084

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NICHD-NRN-0023

Identifier Type: -

Identifier Source: org_study_id