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STUDY TO COMPARE CAFFEINE AND AMINOPHYLLINE IN THE MANAGEMENT OF APNEA OF PREMATURITY

COMPARATIVE STUDY TO EVALUATE EFFICACY AND ADVERSE EFFECTS OF CAFFEINE AND AMINOPHYLLINE IN THE MANAGEMENT OF APNEA OF PREMATURITY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/014329
Enrollment
100
Registered
2018-05-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- APNEA OF PREMATURITY

Interventions

Intervention1: CAFFEINE: Loading dose 20mg/kg of caffeine citrate over 30 minute intravenously, followed by maintenance dose of 5 mg/kg (2.5 mg/kg of caffeine base) in once daily dosing beginning 24 h

Sponsors

dr soumi kundu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Preterm newborn of less than 36 weeks of gestational age who had more than or equal to 2 episodes of apnea in last 24 hours, not explained by other cause within 7 days of life.

Exclusion criteria

Exclusion criteria: Preterm neonates with major congenital anomalies, babies who required resuscitation at birth or babies with other identifiable causes of apnea (respiratory distress, patent ductus arteriosus, anemia, hypoglycemia, hypocalcemia, hypothermia, hyperbilirubinemia, sepsis, intra-ventricular hemorrhage) were excluded after performing relevant investigations according to standard NICU protocol.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of aminophylline and caffeine in management of Apnea of prematurity which will be done by calculating the â??apnea frequencyâ??. Apnea frequency is defined as the average number of apneic attacks per 100 minutes.Timepoint: To compare the efficacy of aminophylline and caffeine in management of Apnea of prematurity which will be done by calculating the â??apnea frequencyâ?? on the day of initiating the either drug (â??Day 0â??) followed by 24 hours after the loading dose ("Day 1") and again 4 days later ("Day 5") using cardiorespiratory monitoring data.. Apnea frequency is defined as the average number of apneic attacks per 100 minutes—

Secondary

MeasureTime frame
requirement of CPAP orMechanical ventilation and adverse reactions to both drugs in study subjects.After discharge at1 year of age for neurodevelopmental outcome including motor development, weight gain, length and head circumference.Timepoint: during hospital stay and at 1 year of age—

Countries

India

Contacts

Public ContactDr Soumi Kundu

R,G. KAR MEDICAL COLLEGE AND HOSPITAL

malaydasgupta@hotmail.com9433025004

Outcome results

None listed

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