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Comparing Two Strategies in Adjusting Fraction of Inspired Oxygen to Achieve the Target Oxygen Saturation during Neonatal Resuscitation: A Randomized Comparative Trial

Comparing Two Strategies in Adjusting Fraction of Inspired Oxygen to Achieve the Target Oxygen Saturation during Neonatal Resuscitation: A Randomized Comparative Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260509001
Enrollment
88
Registered
2026-05-09
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm infant requiring oxygen supplementation during resuscitation Preterm resuscitation oxygen saturation

Interventions

1. When the infant is born and assessed to require supplemental oxygen for breathing, measure oxygen saturation immediately on the right hand and start with an initial oxygen concentration of 30%. 2.
Experimental Procedure/Surgery,Experimental Procedure/Surgery
20% every 30 seconds ,30% every 30 seconds

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Months

Inclusion criteria

Inclusion criteria: 1 Preterm GA 24 to 34+6 weeks neonates 2 Require oxygen during resuscitation at delivery rooms at Ramathibodi hospital, SDMC, CNMI (PPV, CPAP or ETT)

Exclusion criteria

Exclusion criteria: 1. Prenatal diagnosis of cyanotic heart disease 2. Newborn expected to require advance resuscitation(airway anomaly, lung hypoplasia, severe hydrop fetalis, CDH) 3. Chromosomal abnormalities

Design outcomes

Primary

MeasureTime frame
Amount of time spending in target oxygen saturation(%) Completed neonatal resuscitation The proportion of time that oxygen saturation remains within the target range compared to the total time of neonatal resuscitation, expressed as a percentage.

Secondary

MeasureTime frame
Percentage of infants achieving target oxygen saturation(SpO2 80-85%) at 5 minutes Completed neonatal resuscitation Percentage of infants achieving target oxygen saturation at 5 minutes

Countries

Thailand

Contacts

Public ContactPracha Nuntnarumit

Faculty of Medicine Ramathibodi hospital

pracha.nun@mahidol.ac.th022011816

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026