Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2014-12-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Premature infants
Premature infants \<29 weeks birth gestational age receiving caffeine per standard of care for the prevention or treatment of apnea of prematurity.
Caffeine
Given per standard of care.
Interventions
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Caffeine
Given per standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \<29 weeks birth gestational age
* Postnatal age ≤15 days
* Receiving caffeine (intravenous or oral) per standard of care for prevention or treatment of apnea of prematurity
Exclusion Criteria
15 Days
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Phillip B Smith, MD, MPH, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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North Carolina Children's Hospital
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Zhao J, Gonzalez F, Mu D. Apnea of prematurity: from cause to treatment. Eur J Pediatr. 2011 Sep;170(9):1097-105. doi: 10.1007/s00431-011-1409-6. Epub 2011 Feb 8.
Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.
Janvier A, Khairy M, Kokkotis A, Cormier C, Messmer D, Barrington KJ. Apnea is associated with neurodevelopmental impairment in very low birth weight infants. J Perinatol. 2004 Dec;24(12):763-8. doi: 10.1038/sj.jp.7211182.
Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006 Jun;117(6):1979-87. doi: 10.1542/peds.2005-1707.
Gal P. Caffeine Therapeutic Drug Monitoring Is Necessary and Cost-effective. J Pediatr Pharmacol Ther. 2007 Oct;12(4):212-5. doi: 10.5863/1551-6776-12.4.212. No abstract available.
Blake MJ, Abdel-Rahman SM, Pearce RE, Leeder JS, Kearns GL. Effect of diet on the development of drug metabolism by cytochrome P-450 enzymes in healthy infants. Pediatr Res. 2006 Dec;60(6):717-23. doi: 10.1203/01.pdr.0000245909.74166.00. Epub 2006 Oct 25.
Le Guennec JC, Billon B. Delay in caffeine elimination in breast-fed infants. Pediatrics. 1987 Feb;79(2):264-8.
Xu H, Rajesan R, Harper P, Kim RB, Lonnerdal B, Yang M, Uematsu S, Hutson J, Watson-MacDonell J, Ito S. Induction of cytochrome P450 1A by cow milk-based formula: a comparative study between human milk and formula. Br J Pharmacol. 2005 Sep;146(2):296-305. doi: 10.1038/sj.bjp.0706319.
Supnet MC, David-Cu R, Walther FJ. Plasma xanthine oxidase activity and lipid hydroperoxide levels in preterm infants. Pediatr Res. 1994 Sep;36(3):283-7. doi: 10.1203/00006450-199409000-00003.
Hassoun PM, Yu FS, Cote CG, Zulueta JJ, Sawhney R, Skinner KA, Skinner HB, Parks DA, Lanzillo JJ. Upregulation of xanthine oxidase by lipopolysaccharide, interleukin-1, and hypoxia. Role in acute lung injury. Am J Respir Crit Care Med. 1998 Jul;158(1):299-305. doi: 10.1164/ajrccm.158.1.9709116.
Related Links
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Bedford Laboratories. CAFCIT (caffeine citrate) injection, CAFCIT (caffeine citrate) solution. 2013.
Other Identifiers
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Pro00058253
Identifier Type: -
Identifier Source: org_study_id
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