Apnea of Prematurity
Conditions
Keywords
caffeine citrate, apnea, prematurity
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 rate, lower extubation failure rate and shorter duration of oxygen therapy
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 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.
Interventions
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
No
Inclusion criteria
* • 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 criteria
* • 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enhanced Respiratory Stimulation, Effect of Caffeine Citrate on the stimulation of respiratory system of premature individuals | 2-3 days after starting the intervention | 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. |
Countries
Pakistan
Outcome results
None listed