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

A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug, Caffeine Citrate Injection USP 20 mg/ml of Swiss Parenterals Ltd., in the comparison to reference drug, Peyona 20mg/ml of Chiesi Pharmaceuticals GmbH, Austria in the treatment of Apnea of preterm infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037536

Enrollment

Registered

2021-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O104- Pre-existing secondary hypertension complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Caffeine Citrate Injection USP 20 mg/ml: 1. Loading Dose (Day 1): Caffeine citrate 20 mg/kg body weight will be administered intravenously using a syringe infusion pump over 30 minutes.

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. The change of frequency of apnea episode from baseline in each observation day 2. Time to event: Days until next events occurred intil l next events occurred. (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.) 3. The change of average duration time of apnea episode from baseline in each observation day 4.The change of lowest oxygen saturation during apnea episodes from baseline in each observation day 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	—

Measure

Time frame

1. The change of frequency of apnea episode from baseline in each observation day 2. Time to event: Days until next events occurred intil l next events occurred. (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.) 3. The change of average duration time of apnea episode from baseline in each observation day 4.The change of lowest oxygen saturation during apnea episodes from baseline in each observation day 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

—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt. Ltd.

harish@icbiocro.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026