Effect of prophylactic Caffeine on duration of respiratory support in preterm neonates with RDS

Effect of prophylactic Caffeine on the need for oxygen duration and respiratory support in preterm neonates with weight 1250-2000 gr with RDS requiring nasal CPAP

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170627034782N2

Enrollment

Registered

2019-12-12

Start date

2019-11-11

Completion date

Unknown

Last updated

2019-12-17

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

Conditions

neonatal respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: In the caffeine given group (C), the premature neonate with a weight between 1250-2000 germ and spontaneous breathing with clinical signs and symptoms of RDS and re

Eligibility

Sex/Gender

All

Age

1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Newborns with a gestational age less than 36 weeks and 6 days Birth weight between 1250 and 2000 gram Spontaneous breathing and clinical signs and symptoms of RDS Requiring nasal CPAP

Exclusion criteria

Exclusion criteria: Major congenital anomalies Asphyxia Occurrence of apnea and need to mechanical ventilation in first 24 hours of birth Congenital cyanotic heart disease Sepsis in the first seven days of birth

Design outcomes

Primary

Measure	Time frame
Duration of respiratory support with nasal CPAP. Timepoint: Hourly, since birth till discontinuation of nasal CPAP. Method of measurement: Report in special charts of neonatal intensive care unit every hour.	—

Secondary

Measure	Time frame
Apnea of prematurity. Timepoint: Hourly, since birth till discharge. Method of measurement: Cardio-respiratory monitoring in daily recorded sheet.;Duration of oxygen need. Timepoint: Hourly, since birth till discharge. Method of measurement: Daily recorded sheet.;Duration of hospitalization. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Patent ductus arteriosus. Timepoint: Daily. Method of measurement: Cardiac exam and echocardiography if necessary.;Chronic lung disease. Timepoint: Daily. Method of measurement: Physical exam and chest-xray.;Pneumothorax. Timepoint: Hourly, since birth till discharge. Method of measurement: Physical exam and chest-xray.;Nosocomial infection. Timepoint: Daily. Method of measurement: Blood culture.;Seizure. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Time to full enteral feed. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Intraventricular hemorrhage. Timepoint: Third day of life. Method of measurement: Brain sonography.;Necrotizing enterocolitis. Timepoint: Daily. Method of measurement: Physical exam and abdominal-xray.	—

Measure

Time frame

Apnea of prematurity. Timepoint: Hourly, since birth till discharge. Method of measurement: Cardio-respiratory monitoring in daily recorded sheet.;Duration of oxygen need. Timepoint: Hourly, since birth till discharge. Method of measurement: Daily recorded sheet.;Duration of hospitalization. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Patent ductus arteriosus. Timepoint: Daily. Method of measurement: Cardiac exam and echocardiography if necessary.;Chronic lung disease. Timepoint: Daily. Method of measurement: Physical exam and chest-xray.;Pneumothorax. Timepoint: Hourly, since birth till discharge. Method of measurement: Physical exam and chest-xray.;Nosocomial infection. Timepoint: Daily. Method of measurement: Blood culture.;Seizure. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Time to full enteral feed. Timepoint: Daily. Method of measurement: Daily recorded sheet.;Intraventricular hemorrhage. Timepoint: Third day of life. Method of measurement: Brain sonography.;Necrotizing enterocolitis. Timepoint: Daily. Method of measurement: Physical exam and abdominal-xray.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Iranpour

Esfahan University of Medical Sciences

ramin.iranpour@gmail.com+98 31 3668 1555

Outcome results

None listed

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