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Comparison of synchronised non invasive positive pressure ventilation to continuous positive airway pressure in preterm neonates

Clinical efficacy of synchronized nasal intermittent positive pressure ventilation versus high continuous positive airway pressure as primary mode of respiratory support in preterm neonates(28-34weeks): a randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075784
Enrollment
108
Registered
2024-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: P220- Respiratory distress syndrome of newborn

Interventions

Intervention1: High CPAP: CPAP with PEEP more than 8 cm of H2O will be given till the baby recovers or switched to other non-invasive or invasive mode of ventilation with a duration of maximum 72 hour

Sponsors

IPGME&R and SSKM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Intramural Preterm (28 to 34 weeks GA) neonate within 72 hrs of life with respiratory distress

Exclusion criteria

Exclusion criteria: Major Congenital anomalies Suspected Chromosomal anomalies Requirement of Vasopressor/ mechanical ventilation/ hemodynamically unstable at the time of randomisation Severe Perinatal asphyxia Upper airway anomalies Outborn neonates

Design outcomes

Primary

MeasureTime frame
Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive supportTimepoint: Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support—

Secondary

MeasureTime frame
Duration of respiratory supportTimepoint: At 4 weeks;Requirement of intravenous fluid before reaching full feedsTimepoint: At 2 weeks;Incidence of feed intoleranceTimepoint: At 4 weeks;Incidence of NECTimepoint: At 4 weeks;Incidence of pulmonary air leakTimepoint: At 4 weeks;Incidence of IVHTimepoint: At 4 weeks;Incidence of culture positive sepsisTimepoint: At 4 weeks;Incidence of BPDTimepoint: At 4 weeks;Incidence of hsPDA requiring treatmentTimepoint: At 4 weeks;Incidence of ROPTimepoint: At 4 weeks;Length of NICU stayTimepoint: At 4 weeks—

Countries

India

Contacts

Public ContactRatan Kumar Biswas

Institute of Post Graduate Medical Education and Research, Kolkata

ratansarmistha2011@gmail.com8697700890

Outcome results

None listed

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