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Clinical Trials/NCT02400697
NCT02400697
Completed
Not Applicable

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

Indiana University1 site in 1 country2,856 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intraventricular Hemorrhage
Sponsor
Indiana University
Enrollment
2856
Locations
1
Primary Endpoint
Decrease in common complications of preterm birth
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William A. Engle

Professor of Pediatrics

Indiana University

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

Decrease in common complications of preterm birth

Time Frame: 3 years

Study Sites (1)

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