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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Tuebingen AöR

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Trial duration

1 Jul 2018 → ongoing

Decision date (initial)

2024-08-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

German Federal Ministry for Education and Research (BMBF)

External identifiers

EU CT number

2024-511335-10-01

EudraCT number

2018-000453-41

ClinicalTrials.gov

NCT03168516

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To assess the effect of efficacy of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) provided in standard infant ventilators in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation, continous positive airway pressure (CPAP) or any other positive pressure respiratory support compared to manual adjustments of the FiO2 only on the primary enpoints.

Secondary objectives 1

1. To assess the safety of FiO2-C

Conditions and MedDRA coding

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

Regulatory references

Plan to share IPD

No

IPD plan description

Results will be published in peer reviewed journals

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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

Exclusion criteria 4

1. Decision not to provide full life support / decision for palliative care only before study entry
2. 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)
3. Postnatal age >48h
4. Lack of device enabling closed-loop automatic control of FiO2 before randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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.

Secondary endpoints 1

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Tuebingen AöR

Sponsor organisation

Universitaetsklinikum Tuebingen AöR

Address

Geissweg 3, Innenstadt Innenstadt

City

Tübingen

Postcode

72076

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

Prof. Axel Franz

Public contact point

Organisation

Universitaetsklinikum Tuebingen AöR

Contact name

Prof. Axel Franz

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications