Early inhaled fluticasone use for the prevention of bronchopulmonary dysplasia in premature infants

Phase 3

• Conditions: 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

• Registration Number: TCTR20210929009
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-29
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 146

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia or death until off oxygen or postmenstrual age 36 weeks number