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	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.	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.
Overall Study STARTED	53	45
Overall Study COMPLETED	53	42
Overall Study NOT COMPLETED	0	3

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=5 Participants	29.1 Weeks STANDARD_DEVIATION 1.7 • n=7 Participants	28.9 Weeks STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	45 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	42 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	53 participants n=7 Participants	98 participants n=5 Participants
Mean birth weight	1262.1 grams STANDARD_DEVIATION 265.6 • n=5 Participants	1274.5 grams STANDARD_DEVIATION 270.3 • n=7 Participants	1270.1 grams STANDARD_DEVIATION 267.2 • n=5 Participants

PRIMARY outcome

Timeframe: 35, 36, 37, 38 weeks postmenstrual age

Population: 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 age

Population: 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

Carl E. Hunt, M.D.

Uniformed Services University

Phone: 240-694-2676

Email: carl.hunt@usuhs.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place