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Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00494702
Acronym
OXTOX
Enrollment
88
Registered
2007-07-02
Start date
2005-04-30
Completion date
2008-09-30
Last updated
2008-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Asphyxia, Premature Birth

Keywords

Asphyxia, Resuscitation, Oxidative stress, Prematurity, Follow up

Brief summary

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

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.

Interventions

PROCEDUREResuscitation

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

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Fundacion Para La Investigacion Hospital La Fe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 3 Minutes
Healthy volunteers
No

Inclusion criteria

* Prematurity of less than 28 weeks gestation

Exclusion criteria

* Severe malformations * Chromosomopathies * Informed consent not signed

Design outcomes

Primary

MeasureTime frame
Achievement of a targeted saturation of 85% at 15 min of life.30 min

Secondary

MeasureTime frame
Neonatal mortality28 days of life
Oxidative stressat day 1, 2 and 7
Bronchopulmonary dysplasia36 weeks postconceptional age
Retinopathy of prematurity40 weeks postconceptional
Neurodevelopment24 months postnatal

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026