Preterm infants who receive inhaled corticosteroid may have adverse clinical symptoms such as hyperglycemic episodes requiring insulin treatment, hypertensive episodes requiring antihypertensive treatment. Bronchopulmonary dysplasia Inhaled corticosteroids Preterm infant Prevention
Conditions
Interventions
Fluticasone (Flixotide) metered-dose inhalers providing 125 mcg per actuation. The label on the MDI canisters has been removed by NICU pharmacist as to conceal. The metered dose inhaler containing flu
s face, covering nose and mouth. Fluticasone will be administered from the MDI. Manual inflations will be given through the chamber using a bag, and as soon as chest movements are well established and
Placebo Comparator Drug,Placebo Comparator Drug
Fluticasone ,Placebo (Hydrofluoroalkane propellant)
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
1 Hours to 24 Hours
Inclusion criteria
Inclusion criteria: 1. Born in hospital and admit in PSU NICU 2. Preterm BW less than 1500 g and GA less than or equal 32 weeks 3. Need for assisted, invasive mechanical ventilation within 24 h of life and need noninvasive ventilation (NIV) if extubation 4. Neonate has not been intervened from another RCT study
Exclusion criteria
Exclusion criteria: 1. Major congenital anomalies, chromosomal abnormalities, congenital cyanotic heart disease 2. Grade 4 intraventricular hemorrhage occurring before enrollment 3. Severe birth asphyxia or HIE 4. Palliative care 5. Evidence of sepsis (abnormal laboratory data and/or unexplained circulatory failure) before enrollment 6. Hyperglycemia (blood glucose concentration more than 180 mgdL) before enrollment 7. Hypertension more than 95th percentile of systolic blood pressure by GA before enrollment 8. Parents decision not to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bronchopulmonary dysplasia or death until off oxygen or postmenstrual age 36 weeks number | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for systemic steroid postmenstrual age at 36 weeks number (yes/no),Rate of extubation failure postmenstrual age at 36 weeks number (yes/no),Duration of oxygen used postmenstrual age at 36 weeks number (day),Death before discharge or PMA 36 weeks before discharge or postmenstrual age at 36 weeks number (yes,/no),Proven sepsis postmenstrual age at 36 weeks number (yes/no),ventilator associated pneumonia postmenstrual age at 36 weeks number (yes/no),patent ductus arteriosus requiring treatment postmenstrual age at 36 weeks number (yes/no),hyperglycemia requiring insulin postmenstrual age at 36 weeks number (yes/no),hypertension requiring treatment postmenstrual age at 36 weeks number (yes/no),HPA axis suppression postmenstrual age at 36 weeks serum cortisol, 24-h urine cortisol/creatinine ration,retinopathy of prematurity require treatment postmenstrual age at 36 weeks number (yes/no),intraventricular hemorrhage gr 3-4 postmenstrual age at 36 weeks number (yes/no),periventricular leukomalacia postmenstrual age at 36 weeks number (yes/no) | — |
Countries
Thailand
Contacts
Public ContactGunlawadee Maneenil
Faculty of Medicine, Prince of Songkla University
Outcome results
None listed