Effects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    2340
  • sponsor
    University Hospital Tuebingen
Updated on 26 September 2021

Summary

Extremely low gestational age neonates (ELGANs), i.e. those born at <28 weeks, frequently experience intermittent hypoxemic/hyperoxemic episodes. Observational data indicate that severe and prolonged hypoxemic episodes are associated with retinopathy of prematurity (ROP), impaired long-term development and death. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) reduces time outside the oxygen target range, decreases number and duration of hypo- and hyperoxemic episodes, and reduces caregivers' workload. The proposed observer-blinded randomized controlled trial was designed and will be powered to compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in ELGANs. The results of this trial may help to improve the quality of life of ELGANs and reduce the burden of significant morbidity as well as costs for health care and society

Details
Condition Prematurity
Treatment closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
Clinical Study IdentifierNCT03168516
SponsorUniversity Hospital Tuebingen
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Decision for palliative care
congenital anomalies
postnatal age > 48h
missing parental consent
lack of device enabling closed-loop automatic control of FiO2
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