Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: Surfactant With Budesonide: Intervention group will recieve intratracheal Curosurf at dose 200mg/kg initial dose plus budesonide (0.25 mg or 1 ml/kg).Repeated administrations of surfact
Chiesi Farmaceutici, Parma, Italy)
Repeated administrations of surfactant will be given every 6 hours to infants in the control group, until they required an FIO2 less than 0.3, or received a maximu
Sponsors
None listed
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Extreme preterm 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of BPD or deathTimepoint: 36 weeks of gestation age | — |
Secondary
| Measure | Time frame |
|---|---|
| Mode of respiratory support (HFOV, MV, CPAP, HFNC) Need of multiple dose surfactant Hyperglycemia requiring insulin treatment -Hypertension requiring treatment -Need for postnatal systemic steroidsTimepoint: 36 weeks of gestation age | — |
Countries
India
Contacts
Public ContactKiran Vemireddy
Rainbow Childrenâ??s Hospital
Outcome results
None listed