Intermittent Hypoxia and Caffeine in Infants Born Preterm

Grants and Contracts Details


Each clinical site will be responsible for obtaining local IRB approval and all subsequent amendments and renewals as needed. In coordination with study leadership, clinical site investigators will participate in finalizing the Manual of Operations and in training of research study personnel. Each clinical site will be responsible for assuring readiness for subject recruitment, including having appropriate personnel hired and trained. The research staff at each clinical site will screen all preterm infants in the NICU and identify those subjects eligible for enrollment, enroll eligible infants, and implement the study protocol; including pulse oximeter recordings, coordinate study drug procedures with the investigational drug pharmacy, and obtain salivary sampling for caffeine concentrations. Clinical site investigators will assure that the study protocol is being conducted consistently and according to the established protocols at their site, including performing two brain MRI evaluations if being done at that site. Clinical site investigators will also be responsible for protocol compliance during the study weeks at home, and for coordinating successful completion of the final assessment at study end. The site research staff will ensure that their data collection is complete and accurate, and will provide the Data Coordinating Center (DCC) with periodic reports on study progress. Site investigators will have shared responsibility for review of final data analyses, and abstract and manuscript preparation and review.
Effective start/end date9/7/175/31/24


  • Childrens Research Institute dba Childrens National Research Institute: $14,650.00


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