Pulse Oximetry Measurement and Transfusions

Blood Transfusion Clinical Trial

— POMAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249193
• Other study ID #: DDD603862
• Status: Completed
• Start date: April 2014
• Est. completion date: October 2017

Study information

• Verified date: March 2020
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Gender: All
• Age group: N/A to 6 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion
• Hypoxia
• Hypoxia Neonatal
• Premature

Intervention

Other:
• Transfusion
pRBC and non-pRBC transfusions

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Christiana Care Health Services	Pennsylvania Hospital, Temple University Hospital, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hypoxia	Percent time with oxygen saturations less than 85%, 80% and 75%.	8 hours prior to transfusion and 8 hours after transfusion.