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Not Yet Recruiting NCT05629910

NeO2Matic-Pilot Trial

Conditions: Pre-Term, Respiratory Distress Syndrome, Newborn, Retinopathy of Prematurity, Bronchopulmonary Dysplasia

Sex: All
Ages: N/A – 6 Months
Phase: NA
Enrollment: 30
Sponsor: Rigshospitalet, Denmark

Location: Denmark

Summary

The main goal of this trial is to test if:automated adjustment of supplemental oxygen to preterm infants in noninvasive respiratory support based on feedback from a measurement of blood-oxygen saturationresults in more stable blood-oxygenation compared to routine nurse controlled adjustment of oxygen

Eligibility Criteria

Inclusion Criteria:Newborn infants receiving nHFT via Optiflow 4-8 l/min and FiO2>0.25, requiring adjustments of FiO2 beyond the extra need during care proceduresLikely to be maintained on nHFT during study period of 48 hrsExclusion Criteria:major congenital abnormalitieshemodynamic instability including large PDA with right to left shuntingclinician's concern regarding infant stability.Unstable infants with frequent apneas, predominantly having need for oxygen during apneic events

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05629910). StuddyBuddy aggregates publicly available trial information.