FiO2 Delivered With Neonatal bCPAP

NCT06615427 | Completed

• 1 other identifier: 2024-05506-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Continuous Positive Airway Pressure; Respiratory Therapy

Outcome Measures

Primary Outcomes (2)

• FiO2 delivered

  FiO2 in breathing circuit using an oxygen sensor

  5 minutes

• FiO2 estimated

  FiO2 in breathing circuit estimated from flow meters by clinician

  5 minutes

Other Outcomes (1)

• Adverse events

  up to one hour

Study Arms (1)

Infant treated with bubble CPAP and receiving blended air/oxygen

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study aims to include FiO2 measurements from bCPAP machines in use where the infants have stable spontaneous breathing and not expected to need urgent interventions.

You may qualify if:

• Admitted to Phu San Hanoi Hospital Neonatology Unit
• Bubble CPAP support with added O2
• ≥28 weeks GA
• Stable spontaneous breathing
• Investigation team available

You may not qualify if:

• Unstable infants in need of urgent intervention
• Major congenital malformation
• Known syndrome or neuromuscular disorder
• Circulatory instability with inotropes
• Recently extubated (\<24 h)
• Recent large surgical procedure (\<5 days)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Göteborg University: collaborator
• Hanoi Medical University: collaborator
• Hanoi Obstetrics and Gynecology Hospital: collaborator

Study Sites (1)

Phu San Hanoi Hospital

Hanoi, Hanoi, 118000, Vietnam

Location

Related Links

• WHO guidelines including respiratory care

MeSH Terms

Conditions

Respiratory Distress Syndrome; Infant, Premature, Diseases; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. prof. (Docent)

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: September 28, 2024
• Primary Completion: January 14, 2025
• Study Completion: February 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)