A trial funded by the German Federal Ministry for Education and Research (BMBF) to evalute the effects of closed-loop automatic control of inspiratory fraction of oxygen in comparison to manual control in extremly preterm infants with respect to complications of prematurity potentially related to inadequate administration of oxygen (ROP, BPD, NEC) and mortality as well as the neurocognitive outcome after 24 months.

Phase 1

Conditions: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
MedDRA version: 21.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1Level: PTClassification code 10038933Term: Retinopathy of prematuritySystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.1Level: PTClassification code 10055667Term: Necrotising enterocolitis neonatalSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1Level: PTClassification code 10011912Term: Death neonatalSystem Organ Class: 10018065 - General disorders and administration site conditions
MedDRA version: 21.1Level: LLTClassification code 10071101Term: Primary apnoea of premature newbornsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2018-000453-41-DE

Lead Sponsor: niversity Hospital Tuebingen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2340

Inclusion Criteria

Gestational Age at birth 23+0/7 to 27+6/7 weeks
Are the trial subjects under 18? yes
Number of subjects for this age range: 2340
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Decision not to provide full life support / decision for palliative care only before study entry
•Severe congenital abnormalities (particularly those affecting respiratory, cardiovascular, or gastrointestinal function or long-term neuro-cognitive development, whereas a patent ductus arteriosus or a PFO/ASDII is not considered a congenital anomaly in preterm infants)
•Postnatal age >48h
•Missing parental consent
•Lack of device enabling closed-loop automatic control of FiO2 before randomization