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Effect of different types of respiratory devices on brain blood flow used to help small babies to breathe at birth

Effect of T-piece resuscitator versus self-inflating bag on cerebral hemodynamics in delivery room resuscitation of preterm infants: A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026910
Enrollment
72
Registered
2020-07-30
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: P039- Newborn affected by complication of labor and delivery, unspecified

Interventions

Intervention1: T-piece resuscitator: Preterm neonates with apnea/gasping respiration and/or bradycardia (heart rate 100/min) at birth will be given positive pressure ventilation with T-piece resuscita

Sponsors

All India Institute of Medical Sciences Rishikesh India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn neonates of gestational age between 28+0 weeks to 36+6 weeks 2. Birth weight >= 800 g 3. Having apnea/gasping respiration with/without bradycardia (heart rate <100/min) requiring positive pressure ventilation in the delivery room

Exclusion criteria

Exclusion criteria: 1. Major congenital anomalies 2. Inability to attain parental consent

Design outcomes

Primary

MeasureTime frame
Changes in arterial oxygen saturation (SpO2), heart rate (HR) and cerebralregional oxygen saturation (crSO2) in the first hour of lifeTimepoint: First hour of life

Secondary

MeasureTime frame
1. Need for delivery room intubation 2. Need for surfactant use 3. Need and duration of respiratory support 4. Duration of supplemental oxygen therapy 5. Duration of hospital stay 6. Incidence of adverse events Timepoint: At hospital discharge and at 36 weeks

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

sourabh197@gmail.com09910165425

Outcome results

None listed

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