Caffeine Citrate for Primary Apnea of Prematurity (MoCHA Trial)

Phase 3

Waitlist Available

Led By Waldemar Carlo, MD

Research Sponsored by NICHD Neonatal Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks through 8 weeks post-discharge

Awards & highlights

Pivotal Trial

Summary

This trial is testing if continuing caffeine treatment helps moderately preterm infants who had breathing issues recover faster and spend less time in the hospital. Caffeine citrate, a form of caffeine, is used to stimulate their breathing. Caffeine citrate is widely used in neonatology for treating apnea in preterm infants due to its efficacy and safety.

Eligible Conditions

Primary Apnea of Prematurity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks through 8 weeks post-discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks through 8 weeks post-discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks through 8 weeks post-discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Days Between Randomization and Hospital Discharge

Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge

Secondary study objectives

All-cause Mortality

Number of All-cause Readmissions Within First 4 Weeks Post-discharge

Number of All-cause Readmissions Within First 8 Weeks Post-discharge

+17 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Caffeine CitrateExperimental Treatment1 Intervention

Caffeine citrate at 10 mg/kg/dose (5 mg/kg caffeine base) daily, in hospital. Infants will continue at home on the same dose of caffeine citrate for the first 28 days after hospital discharge.

Group II: PlaceboPlacebo Group1 Intervention

Placebo contains all of the excipients except for the active ingredient, caffeine citrate, (a volume equivalent to 10 mg/kg of caffeine citrate) and given daily. Infants will be continued at home on the same dose of placebo for the first 28 days after hospital discharge.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Caffeine Citrate

2019

Completed Phase 3

~240

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