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

(MoCHA Trial)

Recruiting at 15 trial locations

Overseen By Abhik Das, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: NICHD Neonatal Research Network

Must be taking: Caffeine citrate

Disqualifiers: Respiratory therapy, Apnea monitor, Congenital heart disease, Neuromuscular conditions, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 weeks PMA

827 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should be receiving caffeine treatment or have just stopped it. It seems like the focus is on caffeine treatment, so other medications might not be affected.

What data supports the effectiveness of the drug caffeine citrate?

Research shows that caffeine citrate is effective in reducing apnea (pauses in breathing) in premature infants, with fewer side effects like high heart rate and stomach issues compared to other treatments. ^{1 2 3 4 5}

Is caffeine citrate safe for use in humans?

Caffeine citrate has been used safely in premature infants to treat apnea (breathing pauses), with most adverse events being non-serious and unrelated to the treatment. It is stable in various formulations and conditions, suggesting it is generally safe for human use. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Waldemar Carlo, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

≤35 6/7 weeks post-menstrual age at the time of randomization

Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth

Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive caffeine citrate or placebo daily in the hospital, starting within 72 hours of open label caffeine discontinuation

Up to 48 weeks PMA

Daily administration in hospital

Home Treatment

Infants continue on the same dose of caffeine citrate or placebo at home for the first 28 days after hospital discharge

4 weeks

Weekly contact by research team

Follow-up

Participants are monitored for safety and effectiveness after treatment, with biweekly contact during weeks 5 to 8 post-discharge

4 weeks

Biweekly contact by research team

Treatment Details

Interventions

• Caffeine Citrate
• Placebo

Participant Groups

Group I: Caffeine Citrate Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

NICHD Neonatal Research Network

Lead Sponsor

Trials

62

Recruited

209,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A study of 566 preterm infants showed that a high maintenance dose of caffeine citrate (10 mg/kg per day) significantly reduced the need for high-concentration oxygen and the duration of oxygen therapy compared to a low dose (5 mg/kg per day).

While the high-dose group experienced benefits in respiratory support and reduced incidence of apnea and bronchopulmonary dysplasia, it also had a higher rate of feeding intolerance, indicating a need for further research on this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effect of different maintenance doses of caffeine citrate in the treatment of preterm infants requiring assisted ventilation: a pilot multicenter study. Yang, Y., Lu, KY., Cheng, R., et al.[2022]

Caffeine citrate injection remains stable in various intravenous admixtures and parenteral nutrition solutions when stored at room temperature for up to 24 hours.

This stability suggests that caffeine citrate can be safely used in clinical settings without concerns of degradation during this time frame.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of caffeine citrate injection in intravenous admixtures and parenteral nutrition solutions. Nahata, MC., Zingarelli, J., Durrell, DE.[2019]

A population pharmacokinetic (PPK) model for caffeine citrate was developed using data from 46 preterm infants, providing a tailored approach for treating apnea of prematurity in this population.

The model identified weight and post-natal age as key factors influencing caffeine clearance and distribution, which can help optimize individualized treatment for Chinese premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic study of caffeine citrate in Chinese premature infants with apnea. Guo, A., Zhu, Z., Xue, J., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

Clinical effect of different maintenance doses of caffeine citrate in the treatment of preterm infants requiring assisted ventilation: a pilot multicenter study. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Clinical effect of early or late administration of caffeine citrate in prevention and treatment of apnea in very low birth weight infants]. [2020]

3. Norway pubmed.ncbi.nlm.nih.gov

Aminophylline versus caffeine citrate for apnea and bradycardia prophylaxis in premature neonates. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and side effects of two different doses of caffeine in preventing apnea in premature infants. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical effect and safety of different maintenance doses of caffeine citrate in treatment of apnea in very low birth weight preterm infants: a prospective randomized controlled trial]. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Stability of caffeine oral formulations for neonatal use. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Stability of caffeine citrate injection in intravenous admixtures and parenteral nutrition solutions. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Caffeine Citrate for Apnea of Prematurity: A Prospective, Open-Label, Single-Arm Study in Chinese Neonates. [2020]

9. Australia pubmed.ncbi.nlm.nih.gov

Early high-dose caffeine citrate for extremely preterm infants: Neonatal and neurodevelopmental outcomes. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic study of caffeine citrate in Chinese premature infants with apnea. [2022]