Comparing CPAP Titration Strategies in very preterm infants at birth

Comparing CPAP Titration Strategies in very preterm infants at birth - Comparing CPAP Titration Strategies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49590

Enrollment

Registered

2019-10-14

Start date

2019-11-18

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Prematurity preterm birth

Interventions

HCPAP vs low LCPAP strategy. Infants allocated to the HCPAP (intervention group) will start on 15 or 8 cm H2O CPAP depending on their breathing effort directly after birth. Infants with poor breath

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Infants are eligible when they are born premature (24 0/7 to 29 6/7 weeks of gestation).

Exclusion criteria

Exclusion criteria: Exclusion criteria are significant (congenital) malformations/abnormalities influencing the cardiopulmonary transition at birth. Also, parents who are not sufficient in Dutch or English will not be approached for participation.

Design outcomes

Primary

Measure	Time frame
Primary outcome oxygen saturation in the first 5 minutes after birth.	—

Secondary

Measure	Time frame
Secondary outcome: (physiological parameters) are breathing rate and inter-breath variability, minute volume, SpO2 at 5 minutes after birth, SpO2/FiO2 ratio, heart rate, expired tidal volumes during spontaneous breathing, duration below oxygen saturation target range, heart rate and duration of bradycardia, occurrence and duration of positive pressure ventilation given, supplemental oxygen and incidence and timing of caffeine administration in the delivery room. Mortality and short term morbidities will be noted (surfactant administration, pneumothorax, intubation rate, intraventricular hemorrhages, spontaneous intestinal perforations, death).	—

Measure

Time frame

Secondary outcome: (physiological parameters) are breathing rate and inter-breath variability, minute volume, SpO2 at 5 minutes after birth, SpO2/FiO2 ratio, heart rate, expired tidal volumes during spontaneous breathing, duration below oxygen saturation target range, heart rate and duration of bradycardia, occurrence and duration of positive pressure ventilation given, supplemental oxygen and incidence and timing of caffeine administration in the delivery room. Mortality and short term morbidities will be noted (surfactant administration, pneumothorax, intubation rate, intraventricular hemorrhages, spontaneous intestinal perforations, death).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)