Placental Transfusion Project for Preterm Infants
Placental Transfusion in Preterm Infants Born at Less Than 34 Weeks of Gestation … Role of "Delayed" Cord Clamping and Umbilical Cord Milking
1 other identifier
observational
2,856
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 16, 2017
March 1, 2017
2.3 years
March 24, 2015
March 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in common complications of preterm birth
3 years
Study Arms (2)
<30 wks gestation or 1500 grams
Preterm infants born at participating hospitals
30 wks to <34 wks gestation
Preterm infants born at participating hospitals
Interventions
Outcomes of preterm infants recorded
Eligibility Criteria
Preterm infants less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Engle, MD
Indiana University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
March 24, 2015
First Posted
March 27, 2015
Study Start
September 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
March 16, 2017
Record last verified: 2017-03