Status:
COMPLETED
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Lead Sponsor:
American SIDS Institute
Conditions:
Hypoxia
Eligibility:
All Genders
33-37 years
Phase:
PHASE3
Brief Summary
The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatme...
Detailed Description
Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and...
Eligibility Criteria
Inclusion
- Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
- Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
- Previously tolerated clinical treatment with caffeine
- Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
- Parental consent to enroll in pilot study
Exclusion
- Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
- Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
- Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
- Anticipated inability to meet protocol requirements
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01875159
Start Date
July 1 2010
End Date
December 1 2011
Last Update
March 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Uniformed Services University of Health Sciences
Bethesda, Maryland, United States, 20814