Trial Outcomes & Findings for Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm (NCT NCT01875159)
NCT ID: NCT01875159
Last Updated: 2015-03-17
Results Overview
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
35, 36, 37, 38 weeks postmenstrual age
Results posted on
2015-03-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
53
|
|
Overall Study
COMPLETED
|
42
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Baseline characteristics by cohort
| Measure |
Caffeine
n=45 Participants
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.
|
Active Comparator: no Caffeine
n=53 Participants
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.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational Age
|
28.6 Weeks
STANDARD_DEVIATION 1.7 • n=99 Participants
|
29.1 Weeks
STANDARD_DEVIATION 1.7 • n=107 Participants
|
28.9 Weeks
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
53 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Mean birth weight
|
1262.1 grams
STANDARD_DEVIATION 265.6 • n=99 Participants
|
1274.5 grams
STANDARD_DEVIATION 270.3 • n=107 Participants
|
1270.1 grams
STANDARD_DEVIATION 267.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 35, 36, 37, 38 weeks postmenstrual agePopulation: Intention to treat
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Outcome measures
| Measure |
Caffeine
n=42 Participants
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.
|
Active Comparator: no Caffeine
n=53 Participants
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.
|
|---|---|---|
|
Episodes of Intermittent Hypoxia Per Hour
Week 35
|
3.6 Events per hour
Standard Deviation 4.3
|
8.4 Events per hour
Standard Deviation 8.4
|
|
Episodes of Intermittent Hypoxia Per Hour
Week 36
|
3.8 Events per hour
Standard Deviation 4.5
|
8.2 Events per hour
Standard Deviation 11.5
|
|
Episodes of Intermittent Hypoxia Per Hour
Week 37
|
4.3 Events per hour
Standard Deviation 5.9
|
5.2 Events per hour
Standard Deviation 6.8
|
|
Episodes of Intermittent Hypoxia Per Hour
Week 38
|
4.2 Events per hour
Standard Deviation 5.7
|
4.7 Events per hour
Standard Deviation 6.1
|
PRIMARY outcome
Timeframe: 35, 36, 37, 38 weeks postmenstrual agePopulation: Intention to treat
Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Outcome measures
| Measure |
Caffeine
n=42 Participants
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.
|
Active Comparator: no Caffeine
n=53 Participants
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.
|
|---|---|---|
|
Number of Seconds of Intermittent Hypoxia Per Hour
Week 35
|
50.9 seconds per hour
Standard Deviation 48.1
|
106.3 seconds per hour
Standard Deviation 89.0
|
|
Number of Seconds of Intermittent Hypoxia Per Hour
Week 36
|
49.5 seconds per hour
Standard Deviation 52.1
|
100.1 seconds per hour
Standard Deviation 114.6
|
|
Number of Seconds of Intermittent Hypoxia Per Hour
Week 37
|
58.8 seconds per hour
Standard Deviation 74.1
|
66.8 seconds per hour
Standard Deviation 75.2
|
|
Number of Seconds of Intermittent Hypoxia Per Hour
Week 38
|
69.3 seconds per hour
Standard Deviation 108.8
|
66.0 seconds per hour
Standard Deviation 74.8
|
Adverse Events
Caffeine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Comparator: no Caffeine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caffeine
n=42 participants at risk
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.
|
Active Comparator: no Caffeine
n=53 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
11.9%
5/42 • Number of events 5
|
0.00%
0/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place