FindTrial
Sign In

A study to compare benefit of synchronised non invasive ventilation versus traditional non synchronized ventilation in premature neonates with respiratory distress The meaning of synchronisation is to adjust the machine delivered breaths simultaneous with babies own respiratory effort.

Comparison of synchronised non invasive positive pressure ventilation (sNIPPV), non synchronized non invasive positive pressure ventilation(nsNIPPV) and nasal continuous positive airway pressure(nCPAP) as a primary mode of respiratory support in preterm neonates(28-34weeks of gestation ) with respiratory distress syndrome : a 3-arm Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045661
Enrollment
162
Registered
2022-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: synchronised non invasive positive pressure ventilation (sNIPPV): non invasive positive pressure ventilation through synchronisation with patients own respiratory effort (with aid of pr

Sponsors

SSKM IPGMER hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants born between 28 weeks of gestation and � 34 weeks of gestation, presenting with Respiratory Distress Syndrome

Exclusion criteria

Exclusion criteria: ââ?¬Â¢ Outborn babies ââ?¬Â¢ Major lethal congenital anomalies or known/suspected chromosomal anomalies ââ?¬Â¢ Upper airway anomalies(i.e ââ?¬â?? Cleftlip/palate , Midface hypoplasia , Choanal atresia ) ââ?¬Â¢ Shock requiring at least one inotropes ââ?¬Â¢ Intubated at birth ââ?¬Â¢ Participation in another randomized interventional trial ââ?¬Â¢ Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Treatment failure within 72 hours of initiation of primary respiratory supportTimepoint: within 72 hours of initiation of primary respiratory support—

Secondary

MeasureTime frame
ââ?¬Â¢ Duration of respiratory support ââ?¬Â¢ Necrotizing Enterocolitis (Stage 2 and above ) ââ?¬Â¢ Sepsis(only culture proven ) ââ?¬Â¢ Incidence of gastrointestinal perforation (confirmed on roentgenogram or surgical exploration) ââ?¬Â¢ Incidence of Pulmonary air leak including pulmonary interstitial emphysema (PIE), pneumomediastinum and pneumothorax (confirmed on xray) ââ?¬Â¢ Intraventricular hemorrhage on cranial ultrasound, grade 3 and above ââ?¬Â¢ Feed Intolerance ââ?¬Â¢ Incidence of Retinopathy of prematurity (ROP) requiring treatment ââ?¬Â¢ Incidence of Bronchopulmonary Dysplasia (BPD) ââ?¬Â¢ Number of mortality (all causes within NICU stay/ upto 28 days) ââ?¬Â¢ Length of stay in NICU Timepoint: from birth till discharge/death—

Countries

India

Contacts

Public ContactDr Bijan Saha

sskm/ipgmer hospital

bijansaha18@gmail.com9051389120

Outcome results

None listed

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