A randomized control study comparing two doses of caffeine for apnea of prematurity in tertiary care center.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To compare frequency of apnea and the duration of days with apneic episodes in a higher and standard dose of Caffeine for Apnea in Prematurity
Study Overview
Brief Summary
Caffeine is the most commonly used methyl xanthine for the prevention of apnoea in prematurity, but the ideal dose was uncertain, until now. This randomised control study compareS two doses of caffeine for the prevention of apnoea in prematurity. We plan to conduct a clinical trial on 120 preterm infants 30 to 34 weeks in Neonatal Intensive Care Unit. After randomly allocating to receive the intervention (loading 40 mg/kg/day and maintenance of 20 mg/kg/day) or the control (loading 20 mg/kg/ and maintenance of 10 mg/kg/day) dose of caffeine. The primary outcome of the study is to asses frequency and total days of apnea per duration of treatment for both groups. Also other outcomes like duration of respiratory supports and its adverse effects are also being compared.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 0.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All new-borns intramuraly delivered with 30 to 34 week GA admitted in Neonatal intensive care, Department of Paediatrics, R.N.T. Medical College, Udaipur, Rajasthan.
Exclusion Criteria
- •Severe respiratory distress syndrome,Neonates requiring mechanical ventilation ,Sepsis (culture proven),Neonates with congenital malformation, Maternal drug use (MgSO4, morphine),Severe intra-ventricular haemorrhage,Newborns requiring Resuscitation,Parents refusing for consent.
Outcomes
Primary Outcomes
To compare frequency of apnea and the duration of days with apneic episodes in a higher and standard dose of Caffeine for Apnea in Prematurity
Time Frame: daily and to stop once the neonate remains apnea free for 7 days.
Secondary Outcomes
- To compare duration of non-invasive ventilation & duration of oxygen therapy (nasal prong oxygen),time to reach full enteral feeds & adverse effects of caffeine citrate(duration of hospital stay)
Investigators
Dr Gopi Naath
R.N.T Medical college