Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety and efficacy

Conditions

Preterm infants with a gestational age (GA) at birth of 23+0/7 – 27+6/7 weeks

Brief summary

The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital, The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.

Detailed description

Individual components of the primary outcome variables and developmental scores of the Bayley Scales of Infant Development (3rd edition)

Related papers

No related papers found yet.

Interventions

DRUGOXYGEN PH.EUR.

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital, The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.	—

Measure

Time frame

The primary outcome I is a composite of any of the following: • Death • Severe retinopathy of prematurity (severe ROP, as defined in 7.3.1) • Chronic lung disease of prematurity (BPD, according to the physiological definition as defined in 7.3.2) • Necrotizing enterocolitis (NEC, as defined in 7.3.3) until discharge from hospital, The primary outcome II is a composite of any of the following: • death or neurodevelopmental impairment (defined as at least one of the following components: motor disability (GMFCS 2-5), language or cognitive delay (language composite score < 85 or cognitive composite score < 85 on Bayley Scales of Infant Development, 3rd edition) or severe visual or hearing impairment (need for a hearing aid or cochlear implant)) at 24 months corrected age.

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Secondary

Measure	Time frame
Individual components of the primary outcome variables and developmental scores of the Bayley Scales of Infant Development (3rd edition)	—

Countries

Germany

Outcome results

None listed