MoCHA
Trial question
What is the role of extended caffeine treatment in moderately preterm infants?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 827
827 patients (420 female, 407 male).
Inclusion criteria: preterm infants born at 29-33 weeks of gestation who at 33-35 weeks of postmenopausal age were receiving caffeine treatment with plans to discontinue it plus receiving full feeds.
Key exclusion criteria: respiratory therapy; infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history; parental request for apnea monitor; congenital heart disease other than atrial septal defect, ventricular septal defect, or patent ductus arteriosus; neuromuscular conditions affecting respiration; major congenital malformation and/or genetic disorder.
Interventions
N=416 caffeine (oral caffeine citrate 10 mg/kg/day through hospital stay and 28 days after discharge).
N=411 placebo (matching placebo through hospital stay and 28 days after discharge).
Primary outcome
Median days of hospitalization
18 days
16.5 days
18.0 days
13.5 days
9.0 days
4.5 days
0.0 days
Caffeine
Placebo
No significant
difference ↔
No significant difference in median days of hospitalization (18 days vs. 16.5 days).
Secondary outcomes
No significant difference in median days to physiological maturity (14 days vs. 15 days; MD -1, 95% CI -2.4 to 0.4).
Significant decrease in median days to apnea or bradycardia free for 5 consecutive days (6 days vs. 10 days; MD -2.7, 95% CI -3.4 to -2).
No significant difference in median days to full oral feeding (7.5 days vs. 6 days).
Safety outcomes
No significant difference in adverse events.
Conclusion
In preterm infants born at 29-33 weeks of gestation who at 33-35 weeks of postmenopausal age were receiving caffeine treatment with plans to discontinue it plus receiving full feeds, caffeine was not superior to placebo with respect to median days of hospitalization.
Reference
Waldemar A Carlo, Eric C Eichenwald, Benjamin A Carper et al. Extended Caffeine for Apnea in Moderately Preterm Infants: The MoCHA Randomized Clinical Trial. JAMA. 2025 Apr 28:e255791. Online ahead of print.
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