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Comparison between Bubble Non Invasive Ventilation and Ventilator Non Invasive ventilation in babies more than 28 weeks

Comparison of delivered distended pressure in the orophayrnx in neonates in Bubble NIPPV and Ventilator NIPPV in more than 28 weeks of gestation with respiratory distress

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052969
Enrollment
78
Registered
2023-05-22
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: J988- Other specified respiratory disorders

Interventions

Intervention1: Bubble NIPPV: Babies will be put on bubble NIPPV for respiratory distress within 6 hours after birth .and pressure delivered will be measured by manometer Control Intervention1: Ventila

Sponsors

Department of Neonatology Institute of obstetrics and Gynecology Madras Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: all Neonates more than 28 weeks of gestation and more than 1 kg ,with respiratory distress developed within 6 hours of life

Exclusion criteria

Exclusion criteria: Delivery room intubation Major congenital /lethal anomalies Birth asphyxia ,with APGAR score of less than 6 at 5 min

Design outcomes

Primary

MeasureTime frame
Delivered distended pressure in Bubble NIPPV and Ventilator NIPPV in neonates more than 28 weeks of gestation with respiratory distressTimepoint: Pressure delivered will be measured at 0 , 12 hours and 24 hours after starting intervention—

Secondary

MeasureTime frame
Duration of respiratory supportTimepoint: total number of days on which baby on respiratory support ,weaned to room air;Failure of deviceTimepoint: pressure requiring more than 24/7 and 20/7 in ventilator NIPPV and Bubble NIPPV to maintain spo2 with one of the following ,ph 7.2 pCO2 60 mmHg , apnea more than 3 per hour , Apnea requiring Bag and Mask ventilation , spo2 less than 85 % with maximum seetting;Need of surfactant in pre term babyTimepoint: as CPG 2021 guidelines , spo2 more than 30 % on maximum setting of device;To compare the complicationsTimepoint: Feed intolerance , defined by vomiting more than 2 episodes and abdomen distension , Air leaks;total length of hospital stay in both groupTimepoint: total number of days after which baby discharged or dies—

Countries

India

Contacts

Public ContactMangalabharathi

Professor of Neonatology and Head of the department ,institute of obstetrics and Gynecology

drmangalabharathi@outlook.com9840786836

Outcome results

None listed

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