Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American SIDS Institute
• Treatments: Caffeine; Caffeine citrate; Citric Acid

Criteria

Inclusion Criteria:

1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization

2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization

3. Previously tolerated clinical treatment with caffeine

4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)

5. Parental consent to enroll in pilot study

Exclusion Criteria:

1. 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

2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy

3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped

4. Anticipated inability to meet protocol requirements