![]() ![]() 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.On respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation).Ability to start study medication within 72 hours after stopping caffeine.Receiving feeds at a volume of ≥120 ml/kg/day by oral and/or tube feeding.Receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment.≤35 6/7 weeks post-menstrual age at the time of randomization. ![]() admitted to hospitals of the NICHD NRN who, are at time of enrollment:.Inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth.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. The parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. 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). 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. 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. 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. Study subjects will be patients in the NICU at one of the participating hospitals at a Neonatal Research Network site. Why Should I Register and Submit Results?. ![]()
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