Are Aminophylline and Caffeine equally effective in preventing long term lung problems in premature babies?

Early Aminophylline versus Caffeine in Very Preterm Neonates and Neonatal Chronic Lung Disease - a randomized controlled, non-inferiority trial - AminoCaP-BPD

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060258

Enrollment

276

Registered

2023-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: P271- Bronchopulmonary dysplasia originating in the perinatal period

Interventions

Intervention1: aminophylline: Inj. Aminophylline 5.5 mg/kg IV loading dose followed by 1.5 mg/kg/dose every 8 hours till clinically stable. The drug is converted to oral etophylline/ theophylline form

Eligibility

Inclusion criteria

Inclusion criteria: Preterm neonates born at less than 32 weeks gestational age.

Exclusion criteria

Exclusion criteria: Neonates with major congenital anomalies of heart or lung or mothers with history of preterm prelabour rupture of membranes (PPROM) before 24 weeks’ gestation.

Design outcomes

Primary

Measure	Time frame
To determine whether early initiation of aminophylline is non-inferior to caffeine citrate in preventing neonatal chronic lung disease in very preterm neonates (born at or below 32 weeks gestation)Timepoint: at 36 weeks corrected gestational age	—

Secondary

Measure	Time frame
Need for mechanical ventilation at 72 hours & 7 daysTimepoint: 72 hours & 7 days;Incidence of Bronchopulmonary dysplasia as defined by NICHD criteriaTimepoint: at 36 weeks corrected gestational age;Frequency of apnoeic episodes & Time for resolution of apnoeic episodes since birthTimepoint: from birth till discharge;Feed intolerance & Time to reach enteral feeds > 150ml/kg/dayTimepoint: from birth till discharge;Tachycardia (>180/min)Timepoint: until stopping the methylxanthine drug;Duration of hospital stayTimepoint: till discharge or death;Hospitalization cost per baby until dischargeTimepoint: till discharge or death;To measure serum concentrations of theophylline, caffeine & etophylline in neonates administered parenteral and oral caffeine/aminophylline/ Etophylline-TheophyllineTimepoint: trough level once each when intravenous medicine & oral medicine are being used.;To assess if any correlation exists between the concentrations of theophylline, caffeine, etophylline & clinical status of the neonateTimepoint: till the medicines are discontinued or until discharge	—

Measure

Time frame

Need for mechanical ventilation at 72 hours & 7 daysTimepoint: 72 hours & 7 days;Incidence of Bronchopulmonary dysplasia as defined by NICHD criteriaTimepoint: at 36 weeks corrected gestational age;Frequency of apnoeic episodes & Time for resolution of apnoeic episodes since birthTimepoint: from birth till discharge;Feed intolerance & Time to reach enteral feeds > 150ml/kg/dayTimepoint: from birth till discharge;Tachycardia (>180/min)Timepoint: until stopping the methylxanthine drug;Duration of hospital stayTimepoint: till discharge or death;Hospitalization cost per baby until dischargeTimepoint: till discharge or death;To measure serum concentrations of theophylline, caffeine & etophylline in neonates administered parenteral and oral caffeine/aminophylline/ Etophylline-TheophyllineTimepoint: trough level once each when intravenous medicine & oral medicine are being used.;To assess if any correlation exists between the concentrations of theophylline, caffeine, etophylline & clinical status of the neonateTimepoint: till the medicines are discontinued or until discharge

—

Countries

India

Contacts

Public ContactDhayaguruvasan M

Christian Medical College Vellore

dhayaguruvasan@gmail.com8056717099

Outcome results

None listed

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