Status:
ACTIVE_NOT_RECRUITING
Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.
Lead Sponsor:
Nishtar Medical University
Conditions:
Apnea of Prematurity
Eligibility:
All Genders
1-10 years
Phase:
PHASE1
Brief Summary
High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success r...
Detailed Description
Apnea of prematurity (AOP) is a common condition in preterm infants due to immature respiratory control, affecting up to 80% of those under 1000 grams. It can lead to serious complications, including ...
Eligibility Criteria
Inclusion
- • Patients with a gestational age of ≥32 and \<37 weeks at birth on LMP.
- Diagnosis of apnea of prematurity (AOP) established as per operational definition within the first 10 days of life.
- Either male or female patients
Exclusion
- • Patients diagnosed with Hydrops fetalis (evaluated through medical record).
- 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.
Key Trial Info
Start Date :
June 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06905496
Start Date
June 3 2024
End Date
March 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
Nishtar Medical Hospital, Multan
Multan, Punjab Province, Pakistan, 60000