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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caffeine | Experimental | Caffeine citrate 6 mg/kg/day |
|
| Active Comparator: no caffeine | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine citrate 6 mg/kg/day | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of Intermittent Hypoxia Per Hour | Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation | 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 | 35, 36, 37, 38 weeks postmenstrual age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Betty McEntire, PhD | American SIDS Instittute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniformed Services University of Health Sciences | Bethesda | Maryland | 20814 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24445955 | Result | Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caffeine | Caffeine citrate 6 mg/kg/day Caffeine citrate 6 mg/kg/day: 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. |
| FG001 | Active Comparator: no Caffeine | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caffeine | Caffeine citrate 6 mg/kg/day Caffeine citrate 6 mg/kg/day: 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. |
| BG001 | Active Comparator: no Caffeine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Episodes of Intermittent Hypoxia Per Hour | Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation | Intention to treat | Posted | Mean | Standard Deviation | Events per hour | 35, 36, 37, 38 weeks postmenstrual age |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caffeine | Caffeine citrate 6 mg/kg/day Caffeine citrate 6 mg/kg/day: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carl E. Hunt, M.D. | Uniformed Services University | 240-694-2676 | carl.hunt@usuhs.edu |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D047928 | Premature Birth |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| C026189 | caffeine citrate |
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|
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. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean birth weight | Mean | Standard Deviation | grams |
|
|
|
|
| Primary | 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 | Intention to treat | Posted | Mean | Standard Deviation | seconds per hour | 35, 36, 37, 38 weeks postmenstrual age |
|
|
|
| 0 |
| 42 |
| 5 |
| 42 |
| EG001 | Active Comparator: no Caffeine | 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. | 0 | 53 | 0 | 53 |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| Week 37 |
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| Week 38 |
|