Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

Phase 3

Completed

• Conditions: Birth Asphyxia; Premature Birth
• Interventions: Procedure: Resuscitation

• Registration Number: NCT00494702
• Lead Sponsor: Fundacion Para La Investigacion Hospital La Fe

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-07-02
• Primary Completion: 2008-03
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-14
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Prematurity of less than 28 weeks gestation

Exclusion Criteria

• Severe malformations
• Chromosomopathies
• Informed consent not signed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LOX	Resuscitation	Low saturation group of premature infants that will be kept within preset limits of 85-89%
HOX	Resuscitation	HOX group of premature infants will be kept within preset saturation limits of 90-93%

Primary Outcome Measures

Name	Time	Method
Achievement of a targeted saturation of 85% at 15 min of life.	30 min

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Servicio de Neonatologia; 🇪🇸 Valencia, Spain