Prematurity preterm birth
Conditions
Interventions
Based on randomization, stabilisation after birth will be started with a FiO2
of either 1.0 or 0.3, after which FiO2 will be titrated based on the oxygen
saturation target range. In both groups, oth
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is respiratory effort in the first 5 minutes after birth expressed as average respiratory minute volume. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are inspired tidal volumes, rate of rise to maximum tidal volumes, percentage of recruitment breaths with tidal volumes above 8 ml/kg and duration of hypoxia and hyperoxia during stabilisation and plasma levels of markers of oxidative stress (8-iso-prostaglandin F2a). | — |
Countries
Netherlands
Outcome results
None listed