Improving respiration with oxygen evaluatio

Recruiting

Conditions: ResuscitationPreterm infantsOxygen

Registration Number: NL-OMON28498

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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, after which FiO2 will be titrated based on oxygen saturation.

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
The main study parameter is respiratory effort, expressed as:<br>-Average respiratory minute volume in the first 5 minutes after birth <br>

Secondary Outcome Measures

Name	Time	Method
Secondary study parameters are;<br /><br>-Interaction of respiratory minute volume in the first 5 minutes after birth with time<br /><br>-Average tidal volumes in the first 5 minutes after birth<br /><br>-Interaction of tidal volumes in the first 5 minutes after birth with time<br /><br>-Average rate of rise to maximum tidal volumes in the first 5 minutes after birth<br /> <br>-Interaction of rate of rise to maximum tidal volumes in the first 5 minutes after birth with time<br>-Percentage of recruitment breaths with tidal volumes above 8 ml/kg in the first 5 minutes after birth<br /><br>-Concentration of 8-iso-prostaglandin F2á(25), an oxidative stress metabolite associated with hyperoxia in blood. This blood sample will be taken together with the sample for measuring standard blood analyses, so that the infant will not be exposed to an extra venepuncture or capillary puncture. <br><br>