Pulse Oximetry Measurement and Transfusions (POMAT)

March 12, 2020 updated by: Kelley Kovatis, Christiana Care Health Services

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature neonates

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transfusion
Other: Transfusion
pRBC and non-pRBC transfusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of Intermittent hypoxia
Time Frame: 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.
Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxia
Time Frame: 8 hours prior to transfusion and 8 hours after transfusion.
Percent time with oxygen saturations less than 85%, 80% and 75%.
8 hours prior to transfusion and 8 hours after transfusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Collaborators

University of Pennsylvania
Temple University Hospital
Pennsylvania Hospital

Investigators

  • Principal Investigator: Kelley Z Kovatis, MD, Christiana Care Health Services, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDD603862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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