Pulse Oximetry Measurement and Transfusions

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.

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Key information

Conditions

Hypoxia Neonatal Asphyxia Neonatorum Blood Transfusion Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases

Age range

Up to 6 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfusion

Other

pRBC and non-pRBC transfusions

Primary outcomes

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.

Secondary outcomes

Hypoxia

Time frame: 8 hours prior to transfusion and 8 hours after transfusion.

Percent time with oxygen saturations less than 85%, 80% and 75%.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

Pennsylvania Hospital
Temple University Hospital
University of Pennsylvania

Registry information

Official study title

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

Acronym: POMAT

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jan 30, 2020
Registry last updated: Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed