NCT03340727.

Study name	Moderately preterm infants with caffeine at home for apnea (MoCHA) trial
Methods	Randomized controlled trial. Parallel assignment
Participants	Inclusion criteria: Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth Admitted to hospitals of the NICHD NRN ≤ 35 6/7 weeks postmenstrual age at the time of randomization Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment Receiving feeds at a volume of ≥ 120 mL/kg/day by oral and/or tube feeding Ability to start study medication within 72 hours after stopping caffeine Exclusion criteria: On respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation) Infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history, including history of a sibling with sudden infant death syndrome 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 Plans to transfer to a non‐NRN site before discharge Unable to obtain parental or guardian consent
Interventions	Group 1: 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 Group 2: 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
Outcomes	Primary outcome: Number of days of hospitalization Secondary outcomes: The number of days to physiologic maturity after randomization PMA at discharge The number of all‐cause hospital re‐admissions The number of all‐cause sick visits Death Weight Elevated heart rate High blood pressure Periods of NPO Reflux Significant apnea Significant bradycardia Arrhythmia Seizures
Starting date	27 February 2019
Contact information	Principal Investigator: Waldemar Carlo, MD, University of Alabama at Birmingham
Comparison
Notes	Primary completion (estimated) March 2023 according to protocol last edited 10 February 2023