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Improving respiration with oxygen evaluation

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28498
Enrollment
50
Registered
2017-12-06
Start date
2018-01-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resuscitation Preterm infants Oxygen

Interventions

Based on randomization, stabilisation after birth will be initiated with a FiO2 of either 1.0 or 0.3, after which FiO2 will be titrated based on oxygen saturation. SpO2 will be measured continuously a

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

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

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

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

Secondary

MeasureTime frame
Secondary study parameters are; - Interaction of respiratory minute volume in the first 5 minutes after birth with time - Average tidal volumes in the first 5 minutes after birth - Interaction of tidal volumes in the first 5 minutes after birth with time - Average rate of rise to maximum tidal volumes in the first 5 minutes after birth - Interaction of rate of rise to maximum tidal volumes in the first 5 minutes after birth with time - Percentage of recruitment breaths with tidal volumes above 8 ml/kg in the first 5 minutes after birth - 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.

Contacts

Public ContactJanneke Dekker

LUMC

j.dekker@lumc.nl071-5266641

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)