Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.
NCT ID: NCT06905496
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
114 participants
INTERVENTIONAL
2024-06-03
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High-Dose Group
High dose group will be administered a loading dose of oral caffeine citrate at 40 mg/kg/day followed by a maintenance dose of 20 mg/kg/day for 7 days
High-Dose
Caffeine
Low Dose
Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.
Low-Dose Group
Low-dose group will receive a loading dose of 20 mg/kg/day and a maintenance dose of 10 mg/kg/day for 7 days
High-Dose
Caffeine
Low Dose
Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.
Interventions
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High-Dose
Caffeine
Low Dose
Caffeine citrate is a combination of caffeine and citric acid, commonly used as a central nervous system stimulant. It is primarily used to treat apnea of prematurity in neonates.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of apnea of prematurity (AOP) established as per operational definition within the first 10 days of life.
* Either male or female patients
Exclusion Criteria
* Patients presenting with major congenital or chromosomal anomalies such as anencephaly, spina bifida, congenital heart defects (e.g., tetralogy of Fallot, transposition of the great arteries), or chromosomal disorders (e.g., trisomy 18, Turner syndrome).
* Presence of a confirmed sepsis through blood culture.
* Presence of a significant underlying neurological disorder evaluated by history and medical records that could contribute to apnea (e.g., intraventricular hemorrhage with posthemorrhagic hydrocephalus, hypoxic-ischemic encephalopathy)
* Patients who have been previously treated with caffeine or other methylxanthines for apnea.
1 Day
10 Days
ALL
No
Sponsors
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Nishtar Medical University
OTHER
Responsible Party
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Fatima Zahra
Post Graduate Resident
Principal Investigators
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Fatima Zahra, FCPS
Role: STUDY_CHAIR
Nishtar Medical University
Locations
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Nishtar Medical Hospital, Multan
Multan, Punjab Province, Pakistan
Countries
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Other Identifiers
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Nishtar Hospital Multan
Identifier Type: OTHER
Identifier Source: secondary_id
HDLDCC2025
Identifier Type: -
Identifier Source: org_study_id
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