Health Condition 1: P284- Other apnea of newborn
Conditions
Interventions
Intervention1: weight adjusted caffeine dose: In the intervention group dose adjustment will be made at weekly intervals from the date of enrolment to maintain the caffeine citrate dose at the same mg
Sponsors
PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: • Gestation less than/equal to 32 weeks • Receiving caffeine citrate (intravenous or oral), as started by the treating team, irrespective of the indication for starting caffeine • Postnatal age >= 10 days with no change in caffeine dose in the previous 72 hrs (this criterion has been introduced as there may be rapid dose changes in the initial days of life before the dose stabilizes)
Exclusion criteria
Exclusion criteria: Life threatening congenital malformations (as they may not live long enough to observe apneas)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the number of significant all-cause apneas.Timepoint: At the time of stoppage of drug or date of discharge/back referral whichever is earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) number of episodes of apneas requiring stimulation b) number of episodes of apneas requiring BMV c) number of episodes of apneas requiring intubation d) number of episodes of apneas not requiring intervention e) number of episodes of apnea requiring increase in dose of caffeine. f) maximum increase in dose of caffeine from baseline, if any g) occurrence of apneas in a 120-hour period of observation after stoppage of caffeine, h) number of episodes of adverse events to caffeine i) incidence of BPD j) incidence of IVH (grade III-IV as per Volpeâ??s grading) k) incidence of NEC (grade of II-III) l) incidence of PVL (grade II-IV as per De Vries grading) m) number of episodes of blood culture positive sepsis m) incidence of ROP requiring treatment n) measurement of serum caffeine levels at the time of enrolment, after 2 weeks and at the time of stopping the medication/discharge/back referral whichever is earlier.Timepoint: At the time of stoppage of drug or date of discharge/back referral whichever is earlier. | — |
Countries
India
Contacts
Public ContactAkshay Jain
PGIMER
Outcome results
None listed