A Phase 3 interventional study of Caffeine citrate 6 mg/kg/day in Hypoxia, sponsored by American SIDS Institute. Completed at 1 site in United States. Open to participants aged 33 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by American SIDS Institute · Phase 3, Interventional, and Treatment
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%.
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.
1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.
This study's enrollment of 98 is above the median of 45 across 853 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →American SIDS Institute is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Caffeine citrate 6 mg/kg/day
Drug: Caffeine citrate 6 mg/kg/day
Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.
Also known as: Cafcit
Episodes of Intermittent Hypoxia Per Hour
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Time frame: 35, 36, 37, 38 weeks postmenstrual age
Number of Seconds of Intermittent Hypoxia Per Hour
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Time frame: 35, 36, 37, 38 weeks postmenstrual age
| Milestone | Caffeine | Active Comparator: no Caffeine |
|---|---|---|
| Started | 45 | 53 |
| Completed | 42 | 53 |
| Not completed | 3 | 0 |
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
| Events per hour | Caffeine | Active Comparator: no Caffeine |
|---|---|---|
| Week 35 | 3.6 ± 4.3 | 8.4 ± 8.4 |
| Week 36 | 3.8 ± 4.5 | 8.2 ± 11.5 |
| Week 37 | 4.3 ± 5.9 | 5.2 ± 6.8 |
| Week 38 | 4.2 ± 5.7 | 4.7 ± 6.1 |
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
| seconds per hour | Caffeine | Active Comparator: no Caffeine |
|---|---|---|
| Week 35 | 50.9 ± 48.1 | 106.3 ± 89.0 |
| Week 36 | 49.5 ± 52.1 | 100.1 ± 114.6 |
| Week 37 | 58.8 ± 74.1 | 66.8 ± 75.2 |
| Week 38 | 69.3 ± 108.8 | 66.0 ± 74.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caffeine | — | 0/42 (0%) | 5/42 (11.9%) |
| Active Comparator: no Caffeine | — | 0/53 (0%) | 0/53 (0%) |
| Event | Caffeine | Active Comparator: no Caffeine |
|---|---|---|
| TachycardiaCardiac disorders | 5/42 | 0/53 |
| Age, Customized(Weeks) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| Gestational Age | 28.6 ± 1.7 | 29.1 ± 1.7 | 28.9 ± 1.7 |
| Sex: Female, Male(Participants) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| Female | 21 | 26 | 47 |
| Male | 24 | 27 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 8 | 10 |
| Not Hispanic or Latino | 40 | 45 | 85 |
| Unknown or Not Reported | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 11 | 9 | 20 |
| White | 27 | 42 | 69 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Region of Enrollment(participants) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| United States | 45 | 53 | 98 |
| Mean birth weight(grams) | Caffeine | Active Comparator: no Caffeine | Total |
|---|---|---|---|
| Mean | 1262.1 ± 265.6 | 1274.5 ± 270.3 | 1270.1 ± 267.2 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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American SIDS Institute