Management of Apnea in Late Preterm and Term Infants
Apnea
About this trial
This is an interventional treatment trial for Apnea
Eligibility Criteria
Our study population will include infants who meet the following criteria: (1) Born at greater than or equal to 34 0/7 weeks gestation; (2) Are assigned a diagnosis of apnea, bradycardia, and/or oxygen desaturations by the primary clinical team; (3) Have met all other discharge criteria (i.e. feeding maturity, temperature regulation, etc.) so that apnea/bradycardia/desaturation remains the final discharge issue.
As our intent will be to study infants for whom hospital stay is prolonged as a result of presumed apnea of prematurity, exclusion criteria will include: (1) comorbidities associated with an increased risk of apnea, including neurologic abnormalities such as congenital CNS malformations, seizures, or intracranial bleeds, anatomic abnormalities of the airway, significant congenital heart disease, residual lung disease requiring respiratory support, infectious disease including sepsis, pneumonia, or meningitis, chromosomal abnormalities, and drug withdrawal; (2) prolonged hospitalization for an indication other than apnea, bradycardia and/or oxygen desaturation such as feeding immaturity, temperature instability, or phototherapy; (3) transfer to an outside hospital; (4) provider concern with caregiver ability to safely operate and comply with home monitor use.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Inpatient Observation
Caffeine and Outpatient Monitoring
Continued inpatient monitoring of apnea, bradycardia, and/or desaturation until an event free period of time (5 days per the current standard of care at each participating institution) has been established and deemed appropriate for discharge home per the discretion of the responsible provider.
Patients will receive a loading dose of caffeine on day 1 with a daily maintenance dose thereafter. Infants will then receive continued inpatient monitoring of apnea/bradycardia/desaturation until an event free period of time has been established and deemed appropriate for discharge home per the discretion of the responsible provider. Infants discharged home on caffeine therapy will receive instructions regarding use of a home monitor. Follow up in the pulmonary clinic will be arranged at 42-43 weeks gestational age. At 43 weeks corrected gestational age, caregivers will be instructed to discontinue caffeine therapy. An outpatient recorded oximetry study will be arranged at least 1 week after discontinuation of caffeine therapy. Home pulse oximetry monitoring will be discontinued if no significant events, as previously defined, are recorded.