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Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants

NCT01773746 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-09-12

No results posted yet for this study

Summary

The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

Conditions

  • Extreme Prematurity - Less Than 28 Weeks

Interventions

OTHER

Neonatal Resuscitation

CPAP or Positive Pressure Ventilation will be provided.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Neil N Finer, MD · UCSD Medical Center

  • Maximo Vento, MD · Hospital La Fe, Valencia Spain

  • Ola D Saugstad, MD, PhD · The National Hospital, Oslo Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-03-01
Completion
2017-03-01

Countries

  • United States
  • Austria
  • France
  • Germany
  • Ireland
  • Italy
  • Poland
  • Russia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom

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 NCT01773746 on ClinicalTrials.gov