Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions

Completed · Not applicable

Conditions studied: Anemia of Prematurity (AOP)

In brief

The primary aim of this study is to determine the mean number of red blood cell (RBC) transfusions received by preterm infants cared for using restrictive Hgb guidelines in combination with splanchnic to cerebral oxygenation ratio (SCOR) assessment compared to the mean number of transfusions received by preterm infants cared for using liberal guidelines alone. This study is designed as a prospective randomized controlled trial. Preterm infants less than 30 weeks gestational age and 500-1250 grams in weight will be recruited and enrolled into the study during day of life 0 to 3. Study participants will be randomly assigned into two groups: a restrictive transfusion group and a liberal transfusion group. In the liberal group, RBC transfusions will be given to subjects when their Hgb level falls below defined values that are based on respiratory support status. In the restrictive group, RBC transfusions will be given to subjects either when their Hgb level falls below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a near-infrared spectroscopy (NIRS) evaluation that demonstrates an SCOR \< 0.73.

Key facts

Study ID

NCT02535208

Run by

NYU Langone Health

People needed

10

Starts

2016-05-16

Expected to finish

2018-10-03

Last updated by the study team

2018-10-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inborn patients (NYULMC and Bellevue Hospital) less than or equal to 30 weeks gestational age
• Less than 1250 grams
• Less than 72 hours old at time of parental consent and study inclusion

You may not qualify if…

• Preterm neonates with 5 minute Apgar score < 3, 10 minute Apgar score < 5, congenital heart disease, alloimmune hemolytic disease, known chromosomal abnormalities, or major malformations will be excluded.
• Preterm neonates with a birth weight of less than 500 grams will also be excluded
• Any patient already diagnosed with intraventricular hemorrhage (IVH), hydrocephalus or a surgical condition prior to recruitment into the study will be excluded.
• Patients receiving high-frequency ventilation at the time of recruitment will be excluded.
• Any preterm infant who has already received > 2 RBC transfusions prior to enrollment will be excluded.

Where it is running

• Bellevue Hospital Center — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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