Comparision of airway administration of drug to open up premature lungs (surfactant) with and without steroids in preventing chronic lung disease in premature babies

Recruiting

Conditions: Other disorders of lung,

Registration Number: CTRI/2020/02/023310

Lead Sponsor: NOT APPLICABLE

Brief Summary: Infants will be randomized into either the intervention group or control group, based on an assignment list designed by a statistician. Concealed randomization will be generated by a computer with permuted blocks in random sizes of six with half of the infants assigned to intervention and half to control. The control group will receive surfactant only (Curosurf - 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable), Chiesi Farmaceutici, Parma, Italy) and the intervention group will receive Curosurf dose 200mg/kg initial dose; subsequent dose 100mg/kg (if applicable) plus budesonide (0.25 mg or 1 ml/kg). This dose will provide a concentration ratio of surfactant to budesonide greater than 50:1; this mixture was demonstrated, in an in vitro study using a surfactometer and high- performance liquid chromatography, not to affect the biophysical and chemical properties of surfactant. Before intratracheal instillation, the syringe will be gently vortexed, and the surfactant or surfactant/budesonide mixture will be administered in a manner similar to that of routine surfactant therapy. Repeated administrations of surfactant/budesonide or surfactant only will be given every 6 hours to infants in the intervention or control group, respectively, until they require an FIO2 less than 0.3, or received a maximum of three doses

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Less than 6 hours of age 2.Receiving mechanical ventilation via an endotracheal tube or non-invasive respiratory support including CPAP, NIPPV and a clinical decision to treat the infant with exogenous surfactant (first or subsequent dose) for RDS 3.Prospective, written, informed parental/guardian consent obtained.

Exclusion Criteria

1.Extreme preterm <24 weeks of gestation 2.Infant is considered non-viable or is not going to be admitted to intensive care 3.Known or suspected major congenital anomaly that is likely to affect respiratory status (eg: upper airway obstruction, severe pulmonary hypoplasia following oligohydramnios, congenital lung malformation, major congenital heart disease).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of BPD or death	36 weeks of gestation age

Secondary Outcome Measures

Name	Time	Method
Mode of respiratory support (HFOV, MV, CPAP, HFNC)	Need of multiple dose surfactant

Trial Locations

Locations (1): Rainbow Childrenâ€™s Hospital
🇮🇳
Hyderabad, TELANGANA, India
Rainbow Childrenâ€™s Hospital
🇮🇳Hyderabad, TELANGANA, India
Kiran Kumar Reddy V
Principal investigator
9010834837
kiran.vemireddy94@gmail.com