A Phase 1 interventional study of High-Dose and Low Dose in Apnea of Prematurity, sponsored by Nishtar Medical University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 1 Day to 10 Days. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Nishtar Medical University · Phase 1, Interventional, and Treatment
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 rate, lower extubation failure rate and shorter duration of oxygen therapy
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 respiratory distress, pulmonary hemorrhage, and developmental delays. Caffeine citrate, a methylxanthine, is widely used for AOP treatment due to its longer half-life and better absorption compared to theophylline. However, the optimal dosage remains uncertain, with varying practices globally.
1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 114 is above the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Nishtar Medical University is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a gestational age of ≥32 and \<37 weeks at birth on LMP.
Exclusion Criteria:
Patients diagnosed with Hydrops fetalis (evaluated through medical record).
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
Drug: High-Dose · Drug: Low Dose
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
Drug: High-Dose · Drug: Low Dose
Caffeine
Also known as: Caffeine Citrate 40mg/kg/day
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.
Enhanced Respiratory Stimulation, Effect of Caffeine Citrate on the stimulation of respiratory system of premature individuals
High dose vs low dose caffeine citrate effect in apnea of prematurity. The concentration of caffeine citrate as 40mg high dose and 20mg low dose will be considered. The measurement tool will be percentage of patients recovering from this high vs low concentration. The effect of caffeine citrate doses on respiratory stimulation of premature babies will be studied. High doses are expected to improve respiratory distress associated with prematurity. Patients will be clinically assessed after the given doses of caffeine citrate and any improvement, if present, will be noted.
Time frame: 2-3 days after starting the intervention
Plan to share: No — Patient privacy will be our priority. Consent will be taken from patient for participation in study.
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Nishtar Medical University