Back to resultsEffects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Primary Purpose
Hypoxia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Caffeine citrate 6 mg/kg/day
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxia focused on measuring Prematurity, Apnea of prematurity, Intermittent hypoxia
Eligibility Criteria
Inclusion Criteria:
- Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
- Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
- Previously tolerated clinical treatment with caffeine
- Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
- Parental consent to enroll in pilot study
Exclusion Criteria:
- Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
- Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
- Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
- Anticipated inability to meet protocol requirements
Sites / Locations
- Uniformed Services University of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Caffeine
Active Comparator: no caffeine
Arm Description
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.
Outcomes
Primary Outcome Measures
Episodes of Intermittent Hypoxia Per Hour
Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01875159
Brief Title
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Official Title
Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American SIDS Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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%.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
Prematurity, Apnea of prematurity, Intermittent hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caffeine
Arm Type
Experimental
Arm Description
Caffeine citrate 6 mg/kg/day
Arm Title
Active Comparator: no caffeine
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Caffeine citrate 6 mg/kg/day
Other Intervention Name(s)
Cafcit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Episodes of Intermittent Hypoxia Per Hour
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
Title
Number of Seconds of Intermittent Hypoxia Per Hour
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
Previously tolerated clinical treatment with caffeine
Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
Parental consent to enroll in pilot study
Exclusion Criteria:
Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
Anticipated inability to meet protocol requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty McEntire, PhD
Organizational Affiliation
American SIDS Instittute
Official's Role
Study Director
Facility Information:
Facility Name
Uniformed Services University of Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24445955
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
We'll reach out to this number within 24 hrs