High versus low initial oxygen to improve the breathing effort of preterm infants at birth

Completed

• Conditions: Prematurity; preterm birth; 10038686; 10028920

• Registration Number: NL-OMON46752
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Preterm infants of 24-30 weeks of gestation will be randomized to start stabilisation after birth with a FiO2 of either 1.0 or 0.3.

Exclusion Criteria

Congenital abnormality or condition that might have an adverse effect on breathing or ventilation, if these conditions are not already diagnosed before birth, including: congenital diaphragmatic hernia, trachea-oesophageal fistula or cyanotic heart disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is respiratory effort in the first 5 minutes after<br /><br>birth expressed as average respiratory minute volume. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are inspired tidal volumes, rate of rise to maximum tidal<br /><br>volumes, percentage of recruitment breaths with tidal volumes above 8 ml/kg and<br /><br>duration of hypoxia and hyperoxia during stabilisation and plasma levels of<br /><br>markers of oxidative stress (8-iso-prostaglandin F2a). </p><br>