Effect of early initiation of hydrocortisone compared to placebo on the prevention of bronchopulmonary dysplasia in premature neonates

Effect of early initiation of hydrocortisone compared to placebo on the prevention of bronchopulmonary dysplasia in premature neonates: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N557

Enrollment

120

Registered

2025-04-30

Start date

2025-05-15

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Bronchopulmonary dysplasia. Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention 1: Intervention group: Hydrocortisone hemisuccinate 0.5 mg/kg twice daily for 7 days, then 0.5 mg/kg once daily for 3 days. Intervention 2: Control group:Dextrose 5% 0.5 mg/kg twice daily

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Age 1 to 28 days Premature neonates Gestational age 34 weeks and less Birth weight less than 1500 grams

Exclusion criteria

Exclusion criteria: Major congenital anomaly Asphyxia Necrotizing enterocolitis Chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Bronchopulmonary dysplasia-free survival rate. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination.;Risk of bronchopulmonary dysplasia. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination.;Mortality rate. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.	—

Measure

Time frame

Bronchopulmonary dysplasia-free survival rate. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination.;Risk of bronchopulmonary dysplasia. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination.;Mortality rate. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.

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Secondary

Measure	Time frame
Need for home oxygen therapy. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.;Duration of need for mechanical ventilation. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.;Adverse events (including infection, hyperglycemia, hypertension). Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination and blood tests.	—

Measure

Time frame

Need for home oxygen therapy. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.;Duration of need for mechanical ventilation. Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By medical record.;Adverse events (including infection, hyperglycemia, hypertension). Timepoint: In the first 28 days of life and at 36 weeks of postmenstrual age. Method of measurement: By clinical examination and blood tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Roya Reisi

Hamedan University of Medical Sciences

r_reisi@yahoo.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026