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Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

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ClinicalTrials.gov Identifier: NCT01875159
Recruitment Status : Completed
First Posted : June 11, 2013
Results First Posted : March 17, 2015
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Carl Hunt, American SIDS Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypoxia
Intervention Drug: Caffeine citrate 6 mg/kg/day
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Caffeine Active Comparator: no Caffeine
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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.

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.
Period Title: Overall Study
Started 45 53
Completed 42 53
Not Completed 3 0
Arm/Group Title Caffeine Active Comparator: no Caffeine Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 45 53 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Weeks
Gestational Age Number Analyzed 45 participants 53 participants 98 participants
28.6  (1.7) 29.1  (1.7) 28.9  (1.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 53 participants 98 participants
Female
21
  46.7%
26
  49.1%
47
  48.0%
Male
24
  53.3%
27
  50.9%
51
  52.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 53 participants 98 participants
Hispanic or Latino
2
   4.4%
8
  15.1%
10
  10.2%
Not Hispanic or Latino
40
  88.9%
45
  84.9%
85
  86.7%
Unknown or Not Reported
3
   6.7%
0
   0.0%
3
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 53 participants 98 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
2
   4.4%
0
   0.0%
2
   2.0%
Black or African American
11
  24.4%
9
  17.0%
20
  20.4%
White
27
  60.0%
42
  79.2%
69
  70.4%
More than one race
2
   4.4%
0
   0.0%
2
   2.0%
Unknown or Not Reported
3
   6.7%
2
   3.8%
5
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 53 participants 98 participants
45 53 98
Mean birth weight  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 45 participants 53 participants 98 participants
1262.1  (265.6) 1274.5  (270.3) 1270.1  (267.2)
1.Primary Outcome
Title Episodes of Intermittent Hypoxia Per Hour
Hide Description 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
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Intention to treat
Arm/Group Title Caffeine Active Comparator: no Caffeine
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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.

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 Number of Participants Analyzed 42 53
Mean (Standard Deviation)
Unit of Measure: Events per hour
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Caffeine, Active Comparator: no Caffeine
Comments >80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour <90% oxygen saturation/hour of recording
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method GEE gamma regression models
Comments [Not Specified]
2.Primary Outcome
Title Number of Seconds of Intermittent Hypoxia Per Hour
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Caffeine Active Comparator: no Caffeine
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 42 53
Mean (Standard Deviation)
Unit of Measure: seconds per hour
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caffeine Active Comparator: no Caffeine
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Caffeine Active Comparator: no Caffeine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Caffeine Active Comparator: no Caffeine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Caffeine Active Comparator: no Caffeine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/42 (11.90%)      0/53 (0.00%)    
Cardiac disorders     
Tachycardia   5/42 (11.90%)  5 0/53 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carl E. Hunt, M.D.
Organization: Uniformed Services University
Phone: 240-694-2676
EMail: carl.hunt@usuhs.edu
Layout table for additonal information
Responsible Party: Carl Hunt, American SIDS Institute
ClinicalTrials.gov Identifier: NCT01875159     History of Changes
Other Study ID Numbers: ASI 01
First Submitted: June 3, 2013
First Posted: June 11, 2013
Results First Submitted: January 14, 2014
Results First Posted: March 17, 2015
Last Update Posted: March 17, 2015