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Suitable oxygen levels to help small babies to breathe at birth

Optimum Oxygen Concentration for Initiation of Delivery Room Stabilization in Preterm Neonates: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048958
Enrollment
150
Registered
2023-01-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: P019- Newborn affected by maternal complication of pregnancy, unspecified

Interventions

Intervention1: Initiation of delivery room stabilization with 60% oxygen followed by subsequent titration to achieve pre-defined oxygen saturation targets: Preterm neonates of gestational age 34 weeks

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inborn preterm neonates with gestational age less than 34 weeks requiring respiratory support for delivery room stabilization as per American Heart Association Neonatal Resuscitation Program (AHA-NRP) 2020 guidelines.

Exclusion criteria

Exclusion criteria: 1. Neonates with birth weight 2. Non availability of oxygen blender at delivery area 3. Major congenital anomalies 4. Inability to obtain parental consent 5. Parental decision - not to resuscitate

Design outcomes

Primary

MeasureTime frame
Proportion of neonates achieving a target oxygen saturation of â?¥80%.Timepoint: At 5 minutes of life.

Secondary

MeasureTime frame
1. Time to achieve HR100/min 2. Time to achieve SpO2 85% 3. Heart rate and SpO2 at different time intervals 4. Cerebral regional oxygen saturation (crSO2) at 1 hour of life 5. Need for delivery room intubation 6. Need for surfactant use 7. Need and duration of respiratory support 8. Duration of supplemental oxygen therapy 9. Duration of hospital stay 10. Final outcome 11. Incidence of adverse events Timepoint: During hospital stay and at discharge

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

9416593940s@gmail.com9416593940

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026