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Use of different levels of pressure to assist breathing on oxygen levels in tiny babies at birth

Effect of Different Levels of Positive End Expiratory Pressure on Oxygen Saturation in Preterm Neonates at Birth: A Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100920
Enrollment
200
Registered
2026-01-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: P289- Respiratory condition of newborn,unspecified

Interventions

Intervention1: During neonatal resuscitation at birth, providing a positive end expiratory pressure of 7-8 cm of water during respiratory stabilization: In neonates requiring positive pressure ventila

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor
Sriparna Basu
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inborn preterm neonates with gestational age less than 34 weeks requiring delivery room respiratory support, either positive pressure ventilation (PPV) or delivery room continuous positive airway pressure (CPAP) as per American Heart Association Neonatal Resuscitation Program guidelines

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Inability to obtain parental consent 3. Parental decision - not to resuscitate

Design outcomes

Primary

MeasureTime frame
Peripheral oxygen saturationTimepoint: At 5 minutes of life—

Secondary

MeasureTime frame
1. Time to achieve heart rate more than 100 per minute 2. Time to achieve peripheral oxygen saturation more than 80% & more than 85% 3. Duration of positive pressure ventilation 4. Need for delivery room intubation, chest compression, & medications 5. Minute-specific heart rate, peripheral oxygen saturation, & fraction of inspired oxygen at different time intervals 6. APGAR score at 5 minutes 7. Lung ultrasound score at NICU admission 8. Incidence of pneumothorax 9. Cerebral regional oxygen saturation at 1 hour 10. Need for surfactant 11. Need & duration of respiratory support in delivery room & in NICU 12. Duration of supplemental oxygen 13. Duration of hospital stay 14. Final outcome 15. Hammersmith Neonatal Neurological Examination score at discharge 16. Incidence of adverse events during hospital stay Timepoint: At baseline, subsequently weekly during hospital stay, & at discharge—

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

me.rakshita@gmail.com9460436995

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026