Pulse Oximetry Measurement and Transfusions
POMAT
Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants
1 other identifier
observational
75
1 country
3
Brief Summary
The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2014
Typical duration for all trials
3 active sites
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
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 24, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedMarch 13, 2020
March 1, 2020
3.5 years
January 24, 2020
March 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in number of Intermittent hypoxia
An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for \>/= 10 secs and \<3 minutes with a minimal time interval of 4 seconds between events.
Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).
Secondary Outcomes (1)
Hypoxia
8 hours prior to transfusion and 8 hours after transfusion.
Study Arms (1)
Transfusion
Interventions
Eligibility Criteria
Premature neonates
You may qualify if:
- +0 to 28+6 weeks gestational age at birth
You may not qualify if:
- Infants with life-limiting diagnoses
- Cyanotic heart disease
- In utero fetal transfusion
- Twin to twin transfusion syndrome
- Isoimmune hemolytic disease
- Severe acute hemorrhage
- Acute shock
- Sepsis with coagulopathy
- Need for perioperative transfusion
- Parents opposed to transfusion of blood
- Parents with hemoglobinopathy or congenital anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christiana Care Health Serviceslead
- Temple University Hospitalcollaborator
- University of Pennsylvaniacollaborator
- Pennsylvania Hospitalcollaborator
Study Sites (3)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelley Z Kovatis, MD
Christiana Care Health Services, Inc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Neonatologist
Study Record Dates
First Submitted
January 24, 2020
First Posted
January 30, 2020
Study Start
April 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
March 13, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share