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Comparison of the effectiveness of high-dose regimens and standard regimens of Caffeine in premature infants

Comparison of therapeutic effects and possible side effects of high dose regimens and standard regimens of Caffeine Citrate in premature neonates

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240929063207N1
Enrollment
60
Registered
2025-01-17
Start date
2025-01-21
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Condition 1: Bronchopulmonary dysplasia. Condition 2: Respiratory distress syndrome. Condition 3: Apnea Of Prematurity. Bronchopulmonary dysplasia originating in the perinatal period Respiratory distress of newborn Other apnea of newborn

Interventions

Intervention 1: Intervention group: Receiving a high dose of caffeine citrate as a 40 mg/kg loading dose, with 20 mg/kg initially, then 10 mg/kg 12 hours and 24 hours after the initial dose, and a mai
loading dose 20 mg/kg and 10 mg/kg for maintenance dose.

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to No maximum

Inclusion criteria

Inclusion criteria: All newborn neonates with gestational age of less than 32 weeks admitted in the first 24 hours of birth Having informed written consent of the legal parents of premature neonates to enter the study

Exclusion criteria

Exclusion criteria: opium withdrawal syndrome respiratory failure( No requirement of fractional concentration of oxygen in inspired gas 80% or more at least for 6 hours and or no requirement of more than of two positive inotropic agents and without considering Hydrocortison significant brain injuries(Intraventricular hemorrhage with grade 3 and 4) congenital anomalies

Design outcomes

Primary

MeasureTime frame
Need O2 therapy. Timepoint: During Hospitalization. Method of measurement: days of O2 therapy.

Secondary

MeasureTime frame
Prematurity complications. Timepoint: during hospitalization. Method of measurement: seizure, intracranial hemorrhage, and Patent ductus arteriosus, necrotising enterocolitis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Amin Mollazadeh

Birjand University of Medical Sciences

Dr.mollazadeh@bums.ac.ir+98 56 3162 2035

Outcome results

None listed

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