Comparison of efficacy and safety of surfactant administration by MIST and INSURE techniques in Respiratory Distress Syndrome.

Phase 3

Recruiting

• Conditions: Surfactant; MIST; InSurE; Surfactant therapyRespiratory distress syndrome; Respiratory distress syndrome; Preterm

• Registration Number: TCTR20210627001
• Lead Sponsor: Self

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-27
• Study Completion: 2021-12-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Neonates of less than 34 weeks of gestation having respiratory distress syndrome fulfilling the following criteria for surfactant administration will be included in the study.
Spontaneously breathing babies worsening on nasal CPAP with FIO2 >30 % and 6cm H2O pressure.

Exclusion Criteria

1)Neonates who were intubated in the delivery room
2)Congenital heart and lung abnormality
3)Neuro muscular disease
4) Neonates with birth asphyxia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
need for invasive mechanical ventilation with in 72 hours after initial extubation indicate by type 2 respiratory failure,radiological improvement 1 Hour Chest XRAY

Secondary Outcome Measures

Name	Time	Method
Effect on pCO2 upto 3 dyas Capillary blood gas,Demand for FiO2 up to 3 days pulse oximetry,radiological improvement 1 hour chest xray,incidence of patent ductus arteriosus during Hospitalization Ecchocardiography,need for second dose of surfactant during hospitalization blood gas analysis,incidence of pneumothorax during Hospitalization chest xray,incidence of pulmonary interstial emphysema during Hospitalization Chest Xray,incidence of pulmonary hemorrhage during Hospitalization direct visualisation and or chest axray,predischarge mortality during Hospitalization death ,duration of nasal CPAP in hours during Hospitalization record of respiratory support,Duration of mechanical ventilation during Hospitalization record of respiratory support,length of hospitalization till discharge hospital Data Record