Delayed Umbilical Cord Clamping in Infants Less Than 32 Weeks

NCT ID: NCT00562536

Last Updated: 2007-11-22

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-11-30

Brief Summary

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The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.

Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.

Detailed Description

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Conditions

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Premature Birth

Keywords

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Umbilical cord clamping Preterm infants Randomized controlled trial For women giving birth to singleton infants 32 weeks gestational age or less

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A 1

Delayed umbilical cord clamping 30-45 seconds.

Group Type EXPERIMENTAL

Umbilical cord clamping

Intervention Type PROCEDURE

Delay of umbilical cord clamping 30 to 45 seconds

A 2

Immediate umbilibcal cord clamping

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Umbilical cord clamping

Delay of umbilical cord clamping 30 to 45 seconds

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation.
* Singleton pregnancy (Note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study).

Exclusion Criteria

* Moderate to life threatening fetal anomalies
* Multiple live gestations at birth (e.g. twins, triplets, etc)
* Intrauterine fetal demise
* Previous participation
* Stem cell collection
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Principal Investigators

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Kellie E Murphy, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Canada

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Kellie E. Murphy, MD MSc

Role: CONTACT

Phone: 416 586-8570

Email: [email protected]

Kelly Chu, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kellie E. Murphy, MD MSc

Role: primary

References

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Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25.

Reference Type DERIVED
PMID: 31875737 (View on PubMed)

Other Identifiers

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Mount Sinai Hospital Toronto

Identifier Type: -

Identifier Source: org_study_id