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Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

NCT00494702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2008-10-15

No results posted yet for this study

Summary

The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.

Conditions

  • Birth Asphyxia
  • Premature Birth

Interventions

PROCEDURE

Resuscitation

Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%

PROCEDURE

Resuscitation

Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundacion Para La Investigacion Hospital La Fe

    lead OTHER

Principal Investigators

  • Maximo Vento, Phd, Md · Hospital Universitario La Fe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
3 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • Spain

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 NCT00494702 on ClinicalTrials.gov