Clinical study to evaluate the Efficacy & Safety of test drug, Caffeine Citrate Injection USP 20 mg/ml of in the treatment of Apnea of preterm infants
- Conditions
- Health Condition 1: O104- Pre-existing secondary hypertension complicating pregnancy, childbirth and the puerperium
- Registration Number
- CTRI/2021/10/037536
- Lead Sponsor
- Swiss Parenterals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
1. Post-conceptional age between 28 weeks and
33 weeks, and over 24 hours after birth.
2. At least 6 episodes of apnea (15-20 seconds
in duration) in 24 hours.
3. Signed written assent from either parent(s)
or legal guardian(s)
1.Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, pneumonia which does not improve even if it treats obstructive apnea.
2.Blood urea nitrogen >20 mg/dL, serum creatinine >1.5 mg/dL
3.Serum AST or ALT >3 times the upper limit of normal.
4.Patients require mechanically-assisted ventilation (containing nasal CPAP)
5.Previous treatment with methylxanthines within 7 days prior to study enrollment.
6.Previous treatment with H2 antagonists (i.e., cimetidine or ranitidine) within 7 days prior to study enrollment.
7.Participant of other clinical trial within 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baselineTimepoint: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
- Secondary Outcome Measures
Name Time Method 1. The change of frequency of apnea episode from baseline in each observation day <br/ ><br>2. Time to event: Days until next events occurred intil l next events occurred. <br/ ><br>(The definition of events are, Not at least 50% reduction of apnea episode Not improving the frequency of episode from baseline Needs mechanical/bag valve mask ventilation.) <br/ ><br>3. The change of average duration time of apnea episode from baseline in each observation day <br/ ><br>4.The change of lowest oxygen saturation during apnea episodes from baseline in each observation day <br/ ><br>5. The proportion of less than 85% oxygen saturation during apnea episodes in each observation dayTimepoint: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day