CompletedNot Applicable

FiO2 Delivered With Neonatal bCPAP

Vietnam100 participantsStarted 2024-09-28

Plain-language summary

Continuous positive airway pressure (CPAP) is the mainstay of treatment recommended for preterm infants with respiratory distress syndrome in all resource contexts. Many of the available bubble CPAP machines in low- and middle-income contexts mix flows of air and oxygen. These are adjusted by two separate rotameters (flowmeters) and estimate FiO2 delivery. Medical decisions regarding interventions to sick neonates such as need for intubation or surfactant administration are in large part dependant on a reliable estimation of FiO2-delivery. The aim of this study is to evaluate the accuracy of FiO2 delivered by bubble-CPAP machines with separate oxygen and air rotameters in patients at a neonatal intensive care unit (NICU) in Hanoi.

Who can participate

Age range3 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Admitted to Phu San Hanoi Hospital Neonatology Unit * Bubble CPAP support with added O2 * ≥28 weeks GA * Stable spontaneous breathing * Investigation team available Exclusion Criteria: * Unstable infants in need of urgent intervention * Major congenital malformation * Known syndrome or neuromuscular disorder * Circulatory instability with inotropes * Recently extubated (\&lt;24 h) * Recent large surgical procedure (\&lt;5 days)

What they're measuring

FiO2 delivered

Timeframe: 5 minutes

FiO2 estimated

Timeframe: 5 minutes

Trial details

NCT IDNCT06615427

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-14

View on ClinicalTrials.gov More Respiratory Distress Syndrome (RDS) trials