Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen

Study Overview
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Brief Summary
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In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a low oxygen delivery strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

Detailed Description
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The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.

Official Title
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Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen

Conditions
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Asphyxia

Intervention / Treatment
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* Other: Resuscitation
* Other: 100% oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inborn infant gestation 34 weeks to 36 weeks 6 days Exclusion Criteria: • known chromosomal or congenital anomalies

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 37 Weeks

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Room air<br>Initiation of resuscitation with 21% Oxygen, adjustments to the inspired oxygen concentration (increased 10%) will be made every 60 seconds for infants to achieve a target SpO2 range of 85-92% | Other: Resuscitation<br>* Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%<br>|
| Active Comparator: 100% Oxygen<br>Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92% | Other: 100% oxygen<br>* Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress status |  | 7 days | 
| oxygen saturations |  | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days on oxygen |  | 28 days | 
| Days on conventional ventilation |  | 28 days | 
| Days on high frequency ventilation |  | 28 days | 
| Days on nasal canula |  | 28 days | 
| Pneumothorax |  | 28 days | 
| Oxygen requirement |  | At 36 weeks adjusted age | 
| Patent ductus arteriosus |  | 28 days | 
| Necrotizing Enterocolitis |  | 28 days | 
| Intracranial hemorrhage |  | 28 days | 
| Hypoxic ischemic encephalopathy |  | 28 days | 
| Retinopathy of prematurity |  | 28 days | 
| Death |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asphyxia, Resuscitation, Room Air