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

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.

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 who, are at time of enrollment:

- ≤35 6/7 weeks post-menstrual 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