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Saturation Targets and Resuscitation in Preterm Trial

NCT03115463 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-01-04

No results posted yet for this study

Summary

The purpose of this research project is to determine if use of optimized target oxygen strategy during delivery room resuscitation can reduce oxidative stress in premature newborns. Objective is to compare oxidative stress markers between preterm neonates resuscitated in the delivery room using three different target oxygen strategies. OX50 target oxygen strategy is currently in use and recommended by neonatal resuscitation program. In this strategy oxygen is adjusted to meet the goal transitional saturations which are approximated 50th centile saturations observed in healthy term newborns. In OX25 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 25th percentile transitional saturations observed in healthy term newborns. In OX75 target oxygen strategy oxygen will be adjusted to meet the goal transitional saturations which are 75th percentile transitional saturations observed in healthy term newborns.

Conditions

  • Oxidative Stress

Interventions

OTHER

Titration of oxygen during neonatal resuscitation

Resuscitation will be initiated at 30% O2 and target goal saturations will be the 10th to 25th percentile saturations in OX25 and 75th percentile in OX75 group. The control group will be resuscitated with the OX50 strategy in which resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines. For the first 6 minutes after birth, target ranges of of all 3 arms are different. After 6 min, the target ranges are are identical.

Sponsors & Collaborators

  • American Academy of Pediatrics

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Vishal Kapadia, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2019-09-30
Completion
2022-09-30

Countries

  • United States

Study Locations

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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 NCT03115463 on ClinicalTrials.gov