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Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

NCT03695900 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-05-10

No results posted yet for this study

Summary

This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).

Conditions

  • Apnea of Prematurity
  • Desaturation of Blood
  • Central Apnea
  • Periodic Breathing
  • Obstructive Apnea of Newborn

Interventions

OTHER

Targeting SpO2 at 93-95%

FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours

OTHER

Targeting SpO2 at 90-92%

FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Nelson Claure, MSc, PhD · University of Miami

  • Eduardo Bancalari, MD · University of Miami

  • Deepak Jain, MD · University of Miami

  • Waleed Kurtom, MD · Jackson Health System

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
18 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-11-08
Completion
2019-11-08

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 NCT03695900 on ClinicalTrials.gov