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Comparison of different devices to establish respiration at birth in tiny babies

T-piece resuscitator versus self-inflating bag for delivery room resuscitation in preterm neonates: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037384
Enrollment
72
Registered
2021-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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: T-piece resuscitator: During delivery room resuscitation, neonates will receive positive pressure ventilation with T-piece resuscitator. Control Intervention1: Self-inflating bag: Durin

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Inborn preterm neonates (gestational age <37 weeks) requiring positive pressure ventilation in delivery room.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Peripheral oxygen saturation (SpO2).Timepoint: At 5 minutes of life.—

Secondary

MeasureTime frame
1. Time to achieve HR100/min 2. Time to achieve SpO2 85% 3. Minute specific HR and SpO2 trends 4. Cerebral regional oxygen saturation (crSO2) trends till 1 hour 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. Incidence of adverse eventsTimepoint: During hospital stay and at discharge.—

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

bhrajishna@gmail.com9492491229

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026