MedTrace Logo

Combining Restrictive Guidelines and a NIRS SCORE to Decrease RBC Transfusions

NCT02535208 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-10-19

No results posted yet for this study

Summary

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.

Conditions

  • Anemia of Prematurity (AOP)

Interventions

OTHER

Restrictive transfusions based on SCOR assessment

RBC transfusions will be given to subjects either when participants' Hgb levels fall 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 NIRS evaluation that demonstrates an SCOR \< 0.73.

OTHER

Liberal transfusions

In the liberal group, RBC transfusions will be given to participants when their Hgb level falls below defined values that are based on respiratory support status, as is standard practice.

Sponsors & Collaborators

Principal Investigators

  • Sean M Bailey, MD · NYU MEDICAL CENTER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-16
Primary Completion
2018-10-03
Completion
2018-10-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535208 on ClinicalTrials.gov