Use of two different CPAP levels during Resuscitation and Treatment of RDS in VLBWI - a randomized controlled multicenter trial

Use of two different CPAP levels during Resuscitation and Treatment of RDS in VLBWI - a randomized controlled multicenter trial - OPTTIMMAL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019940

Enrollment

216

Registered

2020-03-13

Start date

2020-06-02

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

P22.0

Interventions

Group 1: PEEP-level 3-5 cmH2O Group 2: PEEP-level 6-8 cmH2O

Eligibility

Sex/Gender

All

Age

0 Days to 1 Days

Inclusion criteria

Inclusion criteria: GA at birth 26 0/7 to 29+6/7 weeks

Exclusion criteria

Exclusion criteria: 1. Decision not to provide full life support / decision for palliative care only before study entry 2. Preterm infants with severe congenital anomalies affecting breathing control (cerebral anomalies), gas exchange (pulmonary hypoplasia, congenital diaphragmatic hernia) or hemodynamics (cyanotic heart disease). (Remark: whereas a patent ductus arteriosus or a PFO/ASDII is not considered a congenital anomaly in preterm infants) 3. Oligo/anhydramnion present at <22 GA 4. Parents not fluent in German language

Design outcomes

Primary

Measure	Time frame
Need for intubation and mechanical ventilation for > 1h or meeting FiO2- and pCO2-level that indicate the necessity of intubation and mechanical ventilation	—

Secondary

Measure	Time frame
1. Rates of invasive or less invasive surfactant administration 2. Cumulative dose of surfactant in mg/kg birth weight 3. Rate of intubation and invasive mechanical ventilation within the first 120h after birth 4. Duration of invasive mechanical ventilation within the first 120h of life (cumulative hours) 5. Duration of invasive mechanical ventilation until PMA36 or death (cumulative hours) 6. Duration of any respiratory support until PMA36 or death 7. Rate and severity distribution of bronchopulmonary dysplasia (BPD) 8. Rate of discharge with supplemental oxygen 9. Rates of postnatal systemic dexamethasone and/or hydrocortisone for chronic lung disease 10. Rate of inhalative steroids 11. Time to achievement of full enteral feeding 12. Need for Inotropes within the first 120h after birth 13. Need for steroids for treatment of arterial hypotension within the first 120h after birth 14. Rate of PDA-treatment (surgical and/or medical) 15. Rate of retinopathy of prematurity requiring treatment and highest grade 16. Mean FiO2 requirements within the first 120 hours of life 17. Mean PEEP level within the first 120 hours after birth	—

Measure

Time frame

1. Rates of invasive or less invasive surfactant administration 2. Cumulative dose of surfactant in mg/kg birth weight 3. Rate of intubation and invasive mechanical ventilation within the first 120h after birth 4. Duration of invasive mechanical ventilation within the first 120h of life (cumulative hours) 5. Duration of invasive mechanical ventilation until PMA36 or death (cumulative hours) 6. Duration of any respiratory support until PMA36 or death 7. Rate and severity distribution of bronchopulmonary dysplasia (BPD) 8. Rate of discharge with supplemental oxygen 9. Rates of postnatal systemic dexamethasone and/or hydrocortisone for chronic lung disease 10. Rate of inhalative steroids 11. Time to achievement of full enteral feeding 12. Need for Inotropes within the first 120h after birth 13. Need for steroids for treatment of arterial hypotension within the first 120h after birth 14. Rate of PDA-treatment (surgical and/or medical) 15. Rate of retinopathy of prematurity requiring treatment and highest grade 16. Mean FiO2 requirements within the first 120 hours of life 17. Mean PEEP level within the first 120 hours after birth

—

Countries

Germany

Contacts

Public ContactHarald Ehrhardt

Sektion Neonatologie und Pädiatrische Intensivmedizin

Harald.Ehrhardt@uniklinik-ulm.de+49-731 500-57168

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026