Health Condition 1: null- Premature neonates with apnea of prematurity Health Condition 2: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: NIL: Since we are doing an observational study of already administered methylxanthine (either standard doses of Caffeine citrate or Aminophylline) there is neither intervention nor comp
Sponsors
Science and Engineering Research Board
Manipal University Manipal
Eligibility
Inclusion criteria
Inclusion criteria: Preterms ( 6 apneic episodes within 24hr of life, who will be receiving Methylxanthines for AOP.
Exclusion criteria
Exclusion criteria: Congenital anomalies, secondary causes of apnea (sepsis, significant Patent Ductus Arteriosus, Glucose, electrolytes abnormality), receiving drugs with enzyme inducing or inhibiting property, previously receiving Methylxanthine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance and volume of distributionTimepoint: Time of dosing and exact time of blood sampling will be recorded. Every 6th month of sampling (in bulk), plasma samples will be evaluated by LCMS technique to obtain drug clearance and volume of distribution | — |
Secondary
| Measure | Time frame |
|---|---|
| Apnea count, desaturations, Bradycardia, Heart rate, duration of NICU stay, type of and duration of ventilator support, full feed attainment and adverse events.Timepoint: Apnea counts, desaturations, Bradycardia will be noted at every 24 hours. The frequency of individual event will be summed up at the intervals of 1 to 3 days, 4 to 7 days and 8th to 14 days of methylxanthine adminsitration for statistical analysis. Heart rate will be recorded at every 24 hours.Duration of NICU stay, type of and duration of ventilator support, full feed attainment and adverse events will be monitored till discharge from NICU. | — |
Countries
India
Contacts
Public ContactLeslie E Simon Lewis
Kasturba Medical College, Manipal
Outcome results
None listed