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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210627001

Enrollment

106

Registered

2021-06-27

Start date

2021-06-17

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Surfactant therapy Respiratory distress syndrome Surfactant MIST InSurE Respiratory distress syndrome Preterm

Interventions

In INSURE technique , Infants will be intubated with appropriate size endotracheal tube. Surfcatant will be administered gradually and following that positive pressure ventilation will be provide. bab

Experimental Device,Experimental Device

Surfactant Administration through INSURE (intubation,surfactant administration,extubation) technique ,MIST (minimally invasive surfactant therapy) technique

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Pakistan

Contacts

Public ContactAmmara Kaleem

Childrens Hospital and institute of child health

drammarakaleem@gmail.com92 42 99230901

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026