Pulse Oximetry Measurement and Transfusions

Completed

• Conditions: Blood Transfusion; Hypoxia Neonatal; Premature
• Interventions: Other: Transfusion

• Registration Number: NCT04249193
• Lead Sponsor: Christiana Care Health Services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfusion	Transfusion	-

Primary Outcome Measures

Name	Time	Method
Change in number of Intermittent hypoxia	Change 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 Outcome Measures

Name	Time	Method
Hypoxia	8 hours prior to transfusion and 8 hours after transfusion.	Percent time with oxygen saturations less than 85%, 80% and 75%.

Trial Locations

Locations (3)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States