Placental Transfusion Project for Preterm Infants

March 15, 2017 updated by: William A. Engle, Indiana University

Placental Transfusion in Preterm Infants Born at Less Than 34 Weeks of Gestation … Role of "Delayed" Cord Clamping and Umbilical Cord Milking

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2856

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
<30 wks gestation or 1500 grams
Preterm infants born at participating hospitals
Other: <30 wks gestation or 1500 grams
Outcomes of preterm infants recorded
30 wks to <34 wks gestation
Preterm infants born at participating hospitals
Other: <30 wks gestation or 1500 grams
Outcomes of preterm infants recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in common complications of preterm birth
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: William Engle, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1404705195

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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