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Pulse Oximetry Measurement and Transfusions

Effect of Blood Transfusions on Intermittent Hypoxic Episodes in Very Low Birth Weight Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04249193
Acronym
POMAT
Enrollment
75
Registered
2020-01-30
Start date
2014-04-30
Completion date
2017-10-31
Last updated
2020-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Transfusion, Hypoxia Neonatal, Premature

Keywords

Transfusion, Intermittent hypoxia

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.

Interventions

OTHERTransfusion

pRBC and non-pRBC transfusions

Sponsors

Temple University Hospital
CollaboratorUNKNOWN
University of Pennsylvania
CollaboratorOTHER
Pennsylvania Hospital
CollaboratorUNKNOWN
Christiana Care Health Services
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Weeks

Inclusion criteria

* 23+0 to 28+6 weeks gestational age at birth

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in number of Intermittent hypoxiaChange in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).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.

Secondary

MeasureTime frameDescription
Hypoxia8 hours prior to transfusion and 8 hours after transfusion.Percent time with oxygen saturations less than 85%, 80% and 75%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026