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

Phase 3 Terminated 827 enrolled NICHD Neonatal Research Network Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2019-02-27
Primary completion: 2023-01-23
Completion: 2023-03-20

Outcome

Missed primary endpoint

Stopped: “Futility”

paper CONCLUSIONS AND RELEVANCE: In moderately preterm infants, continuation of caffeine treatment compared with placebo did not shorten hospitalization. PMID 40294395 ↗

Publications

Carlo WA, Eichenwald EC, Carper BA, Bell EF, Keszler M, Patel RM, Sanchez PJ, Goldberg RN, D'Angio CT, Van Meurs KP, Hibbs AM, Ambalavanan N, Cosby SS, Newman NS, Vohr BR, Walsh MC, Das A, Ohls RK, Fuller J, Rysavy MA, Ghavam S, Brion LP, Puopolo KM, Moore R, Baack ML, Colaizy TT, Baserga M, Osman AF, Merhar SL, Poindexter BB, DeMauro SB, Kumar V, Cotten CM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Extended Caffeine for Apnea in Moderately Preterm Infants: The MoCHA Randomized Clinical Trial. JAMA. 2025 Jun 24;333(24):2154-2163. doi: 10.1001/jama.2025.5791.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Caffeine	Small molecule	10 mg/kg	Oral