A trial funded by the German Federal Ministry for Education and Research (BMBF) to evaluate 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, NEC, BPD) and mortality as well as the neurocognitive outcome after 24 months

Phase 1

• Conditions: Preterm infants with a gestational age (GA) at birth of 23+0/7 – 27+6/7 weeks; MedDRA version: 21.1Level: LLTClassification code: 10071101Term: Primary apnoea of premature newborns Class: 10038738; MedDRA version: 20.1Level: PTClassification code: 10038933Term: Retinopathy of prematurity Class: 100000004853; MedDRA version: 20.1Level: PTClassification code: 10055667Term: Necrotising enterocolitis neonatal Class: 100000004856; MedDRA version: 20.1Level: PTClassification code: 10011912Term: Death neonatal Class: 100000004867; MedDRA version: 21.1Level: PTClassification code: 10006475Term: Bronchopulmonary dysplasia Class: 100000004855; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2024-511335-10-01
• Lead Sponsor: niversitaetsklinikum Tuebingen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-06
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1082

Inclusion Criteria

GA at birth 23+0/7 to 27+6/7 weeks

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, Lack of device enabling closed-loop automatic control of FiO2 before randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified