Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Birth Asphyxia, Premature Birth

Intervention / Treatment
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* Procedure: Resuscitation
* Procedure: Resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prematurity of less than 28 weeks gestation Exclusion Criteria: Severe malformations Chromosomopathies Informed consent not signed

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LOX<br>Low saturation group of premature infants that will be kept within preset limits of 85-89% | Procedure: Resuscitation<br>* Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-88%<br>|
| Active Comparator: HOX<br>HOX group of premature infants will be kept within preset saturation limits of 90-93% | Procedure: Resuscitation<br>* Oxygen inspiratory fraction needed to keep oxygen saturation in the preset limits of 90-93%<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asphyxia, Resuscitation, Oxidative stress, Prematurity, Follow up