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Methylxanthine

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 randomization until eight weeks after discharge up to 52 wks pma

Awards & highlights

MoCHA Trial Summary

This trial is testing whether giving caffeine to premature babies after they leave the hospital can shorten the length of their hospital stay.

Eligible Conditions

Primary Apnea of Prematurity

MoCHA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ discharge until eight weeks after discharge up to 52 wks pma

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~discharge until eight weeks after discharge up to 52 wks pma

This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge until eight weeks after discharge up to 52 wks pma for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of days of hospitalization

Secondary outcome measures

Arrhythmia

Death

Elevated Heart Rate

+11 more

MoCHA 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,673,941 Total Patients Enrolled

NICHD Neonatal Research NetworkLead Sponsor

59 Previous Clinical Trials

204,970 Total Patients Enrolled

Waldemar Carlo, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

9 Previous Clinical Trials

129,366 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Caffeine Citrate given to patients?

"Caffeine Citrate can be used to mitigate symptoms like respiratory depression, pain, and menstruation-associated pain."

Answered by AI

What other scientific papers exist that mention Caffeine Citrate?

"There are a total of 13 caffeine citrate clinical trials currently underway. Out of these, 2 are in the final stage of testing. The majority of these trials are based in Chongqing, but there are 120 locations running these tests in total."

Answered by AI

How many different hospitals or research facilities are participating in this study?

"There are 15 sites currently running this study. A few notable locations are Houston, Salt Lake City and Providence. If you are considering participating, you should choose the clinic nearest to your residence to minimize travel."

Answered by AI

Who meets the requirements to enroll in this clinical trial?

"To qualify for this sleep apnea study, infants must be between 29 and 33 gestational weeks old. Around 800 patients will be enrolled in total."

Answered by AI

Are enrolling any new participants at this time?

"That is correct, the online information does show that the study is still looking for patients. The original posting date was February 27th, 2019 and the most recent update was on January 11th, 2022. They are aiming to have 800 people enrolled from 15 different locations."

Answered by AI

Has the FDA cleared Caffeine Citrate for public consumption?

"Caffeine Citrate is considered safe by our team at Power. It received a score of 3 because it is a Phase 3 trial, meaning that there is not only some data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

Does this research include individuals who are over the age of 50?

"This trial is only for patients aged 29 weeks to 33 weeks. Out of the 662 total studies, this is the 228th study for patients under 18 and the 234th for those over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

2019. "Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03340727.

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