Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- American SIDS Institute
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Episodes of Intermittent Hypoxia Per Hour
Overview
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 treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.
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 heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 33 Weeks to 37 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Caffeine
Caffeine citrate 6 mg/kg/day
Intervention: Caffeine citrate 6 mg/kg/day (Drug)
Outcomes
Primary Outcomes
Episodes of Intermittent Hypoxia Per Hour
Time Frame: 35, 36, 37, 38 weeks postmenstrual age
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Number of Seconds of Intermittent Hypoxia Per Hour
Time Frame: 35, 36, 37, 38 weeks postmenstrual age
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Secondary Outcomes
No secondary outcomes reported
Investigators
Carl Hunt
Research Professor of Pediatrics
American SIDS Institute