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Effect of caffeine administration in prevention of bronchopulmonary dysplasia (BPD)

Comparison of the preventive effect of early caffeine administration with late caffeine administration in occurrence rate of bronchopulmonary dysplasia (BPD) in preterm neonates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160827029535N8
Enrollment
100
Registered
2020-12-26
Start date
2015-10-01
Completion date
Unknown
Last updated
2021-01-05

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: In interventional goup 1 ( early caffeine group ) , the preventive caffeine was started during the first 48 hours of life . At first , Caffeine was administered with a loading dose o

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 30 Days

Inclusion criteria

Inclusion criteria: The preterm neonates with gestational age of 35 weeks or less The preterm neonates with birth weight of 1500 grams or less

Exclusion criteria

Exclusion criteria: The preterm neonates with any underlying condition (e.g. gastrointestinal anomalies, neurological disorders) The preterm neonates with history of receiving any maternal or neonatal relaxant or sedative medications before intervention.

Design outcomes

Primary

MeasureTime frame
Bronchopulmonary dysplasia of preterm neonates. Timepoint: Before intervention and two weeks after the end of intervention (the end of the 36th week of corrected gestational age). Method of measurement: Clinical manifestations and chest-xray findings.

Secondary

MeasureTime frame
Apnea of prematurity. Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Physical examination.;Need of ventilator therapy. Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Number of times from questionnaire.;Duration of ventilatilator therapy. Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: As days from questionnaire.;Duration of hospitalization. Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Number of days from questionnaire.;Intraventricular hemorrhage ( IVH ). Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Physical examination and brain sonographic findings.;Necrotizing enterocolitis ( NEC ). Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Physical examination and abdominal x-ray findings.;Patent ductus arteriosus ( PDA ). Timepoint: Before intervention and the end of intervention ( the end of the 36th week of corrected gestational age ). Method of measurement: Physical examination and echocardiographic findings.;Retinopathy of prematurity ( ROP ). Timepoint: Before intervention and the end of the first month of life. Method of measurement: Retinal examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPeymaneh Alizadeh Taheri

Tehran University of Medical Sciences

p.alizadet@yahoo.com+98 21 7301 3420

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026