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Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks

NCT ID: NCT01819532

Last Updated: 2017-12-11

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-10-31

Brief Summary

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Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.

Detailed Description

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Conditions

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Prematurity

Keywords

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neonate umbilical cord cord milking prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immediate umbilical cord clamping

The umbilical cord will be clamped immediately after delivery.

Group Type ACTIVE_COMPARATOR

Immediate cord clamping

Intervention Type PROCEDURE

The umbilical cord will be clamped and cut immediately after delivery of the neonate.

Cord milking group

The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.

Group Type EXPERIMENTAL

Milking group

Intervention Type PROCEDURE

The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.

Interventions

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Milking group

The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord.

Intervention Type PROCEDURE

Immediate cord clamping

The umbilical cord will be clamped and cut immediately after delivery of the neonate.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Preterm neonates delivered between 24 0/7 and 32 6/7
* Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
* Written parental consent

Exclusion Criteria

* Multiple gestation pregnancies (twins or higher order multiples)
* Rh or other antibody sensitization
* Hydrops fetalis
* Known major congenital abnormality
* Suspected abruptio placentae
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Bienstock, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00046760

Identifier Type: -

Identifier Source: org_study_id