Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230408057850N1

Enrollment

Registered

2023-04-17

Start date

2023-04-21

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Tracheal tube extubating and subsequent apnea in premature neonates. Other apnea of newborn

Interventions

Intervention 1: Intervention group: Caffeine citrate with an initial dose of 20 mg per kilogram of body weight per day and a maintenance dose of 10 mg per kilogram of body weight. Intervention 2: Cont

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Neonates with a gestational age of less than 35 weeks Hemodynamic stability during the first 48 hours after mechanical ventilation

Exclusion criteria

Exclusion criteria: Neonates with congenital obstruction and perforation of the gastrointestinal tract Gastroschisis Congenital diaphragmatic hernia Cyanotic heart diseases Other congenital anomalies

Design outcomes

Primary

Measure	Time frame
Tracheal extubation failure and subsequent apnea. Timepoint: During the hospitalization period. Method of measurement: Physical examination.	—

Secondary

Measure	Time frame
Tachycardia. Timepoint: Duration of treatment. Method of measurement: Cardiac monitoring.;Nutritional intolerance. Timepoint: Duration of treatment. Method of measurement: Physical examination.;Apnea of prematurity. Timepoint: Before and the end of the intervention. Method of measurement: Physical examination.;Duration of use of mechanical ventilation. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Hospitalization period. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Necrotizing enterocolitis. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and abdominal imaging.;Ductus arteriosus remains open. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and echocardiography.	—

Measure

Time frame

Tachycardia. Timepoint: Duration of treatment. Method of measurement: Cardiac monitoring.;Nutritional intolerance. Timepoint: Duration of treatment. Method of measurement: Physical examination.;Apnea of prematurity. Timepoint: Before and the end of the intervention. Method of measurement: Physical examination.;Duration of use of mechanical ventilation. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Hospitalization period. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Necrotizing enterocolitis. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and abdominal imaging.;Ductus arteriosus remains open. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and echocardiography.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Daei Parizi

Kerman University of Medical Sciences

zdaei@kmu.ac.ir+98 34 3132 8000

Outcome results

None listed

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