Oxygen Toxicity in the Resuscitation in Extremely Premature Infants (OXTOX)

October 14, 2008 updated by: Fundacion Para La Investigacion Hospital La Fe

Achievement of a Targeted Saturation in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentration: A Prospective Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized trial enrolling premature infants of less than 28 weeks gestation. Patients are randomly assigned to become resuscitation with an initial oxygen inspiratory fraction (FiO2) of 30% or 90%. Main objective is to reach a target saturation of 85% at 15 min of life.

Immediately after birth pre-and-postductal pulse oximeters are set and oxygen saturation (SpO2) continuously monitored and registered as long as the patient requires oxygen supplementation. FiO2 is stepwise adjusted (increased or decreased 10%) every 90 sec according to heart rate, SpO2 and responsiveness.

Blood samples are drawn from umbilical cord and at day 1, 2 and 7 from peripheral vein to determine oxidative stress markers (GSH, GSSG), angiogenic factors (VEGF, VEGF receptors, Angiopoietin), pro-inflammatory markers (IL8, TNF alfa) and pro-apoptotic markers (Fas Ligand; Cytochrome C).

Urine is collected every day during the first week of life to determine oxidative stress markers (8-oxo-dG; O-tyrosine; F2 isoprostanes; Isofurans).

Babies are followed in the NICU and clinical condition recorded. Serial examinations for ROP and Auditory evoked potentials will be performed. Neurodevelopmental outcome is evaluated at 2 years of postnatal life. Main outcome: Achievement of a target saturation of 85% at 15 min of life. Secondary outcomes: acute complications during delivery; chronic complications (BPD, ROP, IPVH); mortality in the neonatal period.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46009
        • Servicio de Neonatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 3 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prematurity of less than 28 weeks gestation

Exclusion Criteria:

  • Severe malformations
  • Chromosomopathies
  • Informed consent not signed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOX
Low saturation group of premature infants that will be kept within preset limits of 85-89%
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%
Active Comparator: HOX
HOX group of premature infants will be kept within preset saturation limits of 90-93%
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achievement of a targeted saturation of 85% at 15 min of life.
Time Frame: 30 min
30 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Bronchopulmonary dysplasia
Time Frame: 36 weeks postconceptional age
36 weeks postconceptional age
Neonatal mortality
Time Frame: 28 days of life
28 days of life
Oxidative stress
Time Frame: at day 1, 2 and 7
at day 1, 2 and 7
Retinopathy of prematurity
Time Frame: 40 weeks postconceptional
40 weeks postconceptional
Neurodevelopment
Time Frame: 24 months postnatal
24 months postnatal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Para La Investigacion Hospital La Fe

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Maximo Vento, Phd, Md, Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (Estimate)

July 2, 2007

Study Record Updates

Last Update Posted (Estimate)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 14, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIO51O5
  • FISPI05105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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