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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

Tracking Information
First Submitted Date  ICMJE June 3, 2013
First Posted Date  ICMJE June 11, 2013
Results First Submitted Date  ICMJE January 14, 2014
Results First Posted Date  ICMJE March 17, 2015
Last Update Posted Date March 17, 2015
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
  • Episodes of Intermittent Hypoxia Per Hour [ Time Frame: 35, 36, 37, 38 weeks postmenstrual age ]
    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 [ Time Frame: 35, 36, 37, 38 weeks postmenstrual age ]
    Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2013)
Episodes and seconds/hour of intermittent hypoxia [ Time Frame: Baseline and 40 weeks postmenstrual age ]
Intermittent hypoxia: number of episodes per hour of pulse oximeter recording of oxygen saturation to less than 90%, and sec/hour of recording to less than 90%.
Change History Complete list of historical versions of study NCT01875159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
Official Title  ICMJE Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypoxia
Intervention  ICMJE Drug: 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.
Other Name: Cafcit
Study Arms  ICMJE
  • Experimental: Caffeine
    Caffeine citrate 6 mg/kg/day
    Intervention: Drug: Caffeine citrate 6 mg/kg/day
  • No Intervention: 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.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2015)
98
Original Actual Enrollment  ICMJE
 (submitted: June 10, 2013)
105
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
  2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
  3. Previously tolerated clinical treatment with caffeine
  4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
  5. Parental consent to enroll in pilot study

Exclusion Criteria:

  1. 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
  2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
  3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
  4. Anticipated inability to meet protocol requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 33 Weeks to 37 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01875159
Other Study ID Numbers  ICMJE ASI 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carl Hunt, American SIDS Institute
Study Sponsor  ICMJE American SIDS Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Betty McEntire, PhD American SIDS Instittute
PRS Account American SIDS Institute
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP