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FiO2 Delivered With Neonatal bCPAP

NCT06615427 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome (RDS)
  • Infant, Premature, Diseases
  • Infant, Newborn, Diseases

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Hanoi Medical University

    collaborator OTHER

  • Hanoi Obstetrics and Gynecology Hospital

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-28
Primary Completion
2025-01-14
Completion
2025-02-01

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06615427 on ClinicalTrials.gov