Placental Transfusion Project for Preterm Infants

NCT ID: NCT02400697

Last Updated: 2017-03-16

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

Total Enrollment

2856 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-12-31

Brief Summary

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The American College of Obstetrics and Gynecology, American Academy of Pediatrics and the World Health Organization have recently published recommendations related to placental transfusions in preterm infants. This project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in Indiana. Centers involved in this project are also part of the Indiana Vermont Oxford Network (IRB#1003-84). Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Detailed Description

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Centers involved in this project are also part of the Indiana Vermont Oxford Network. Data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the Vermont Oxford Network collection. This project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the ACOG recommendations.

Conditions

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Intraventricular Hemorrhage Sepsis Necrotizing Enterocolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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<30 wks gestation or 1500 grams

Preterm infants born at participating hospitals

<30 wks gestation or 1500 grams

Intervention Type OTHER

Outcomes of preterm infants recorded

30 wks to <34 wks gestation

Preterm infants born at participating hospitals

<30 wks gestation or 1500 grams

Intervention Type OTHER

Outcomes of preterm infants recorded

Interventions

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<30 wks gestation or 1500 grams

Outcomes of preterm infants recorded

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Preterm infants born at participating hospital who are less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation

Exclusion Criteria

* None
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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William A. Engle

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Engle, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Riley Hospital for Children

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1404705195

Identifier Type: -

Identifier Source: org_study_id

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