NCT03340727

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

Randomized Controlled Trial of Home Therapy With Caffeine Citrate in Moderately Preterm Infants With Apnea of Prematurity

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 827 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 29 Weeks – 33 Weeks
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

Detailed description

Study subjects will be patients in the NICU at one of the participating hospitals at a Neonatal Research Network site. Infants who meet the eligibility criteria will be randomized to either caffeine citrate at 10 mg/kg/dose or placebo (equal volume of all the excipients except for the active ingredient, caffeine citrate) to be given daily beginning within 72 hours of open label caffeine discontinuation. The infant may still require hospitalization for observation after discontinuation of open label caffeine or for other discharge issues such as temperature control or feeding tolerance. Once deemed ready for discharge, infants will be continued at home on the same dose of caffeine citrate or placebo for the first 28 days after hospital discharge. On the day of discharge, the parent will be supplied with 28 numbered vials with oral caffeine citrate (intervention group) or placebo at an equivalent volume (placebo group). The parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. A member of the research team will contact the parents to obtain post-discharge information within 72 hours after discharge, once a week for the first 4 weeks, and biweekly during the weeks 5 to 8 after discharge.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DRUG	Caffeine Citrate	The study intervention is caffeine citrate given once daily at 10 mg/kg/day. It is given orally, before hospital discharge and 28 days after discharge.
DRUG	Placebo	The study intervention is placebo given once daily at a volume equivalent to 10 mg/kg of caffeine citrate. It is given orally, before hospital discharge and 28 days after discharge.

Timeline

• Start date: 2019-02-27
• Primary completion: 2023-01-23
• Completion: 2023-03-20
• First posted: 2017-11-13
• Last updated: 2024-07-31
• Results posted: 2024-06-28

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study