Evaluation and comparison of efficacy and adverse drug reactions for single or two divided caffeine dosing to treat apnea of prematurity in preterm neonates

Evaluation and comparison of efficacy and adverse drug reactions for single or two divided caffeine dosing and simulation of pharmacokinetic parameters to treat apnea of prematurity in preterm neonates

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510172342N4

Enrollment

Registered

2017-01-05

Start date

2015-05-06

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Apnea of prematurity. Other preterm infants

Interventions

Intervention 1: control group: dose of 5 mg/ kg once daily group 1. Intervention 2: intervention group: dose of 2.5 mg/ kg twice daily in Group 2.

Treatment - Drugs

control group: dose of 5 mg/ kg once daily group 1

intervention group: dose of 2.5 mg/ kg twice daily in Group 2

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates with gestational age of 37 weeks exclusion criteria: asphyxia, hypoglycemia, intracranial hemorrhage, major inherited anomaly

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Extubation failure. Timepoint: during treatment. Method of measurement: Clinical observations.;CPAP failure. Timepoint: during treatment. Method of measurement: clinical observations and levels of blood gases in ABG.	—

Secondary

Measure	Time frame
Adverse reactions. Timepoint: during the treatment. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Fatemeh Faramarzi

Mazandaran University of Medical Sciences

faramarzif1984@gmail.com00

Outcome results

None listed

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