TABLE OF CONTENTS

 

 

 

 

  1. Overview
  2.  

  3. Briefing Document by Hugo Gallo-Torres, M.D., Ph.D.
  4.  

     

  5. Sample of a Written Request for Proton-Pump Inhibitors Used to Treat Gastroesophageal Reflux Disease
  6.  

  7. Usage data for proton-pump inhibitors in pediatrics
  8.  

  9. Letter from George D. Ferry, M.D.
  10.  

  11. References

 

List of References

Gastroesophageal reflux disease in pediatrics

  1. Faubion, WA, Zein, NN. Gastroesophageal reflux in infants and children. Mayo Clinic Proc. 1998; 73:166-173.
  2. Orenstein, SR. Management of supraesophageal complications of gastroesophgeal reflux disease in infants and children. The American Journal of Medicine. 2000; 108(4A):139S-143S.
  3. Vandenplas,Y, SacrJ -Smits,L. Continous 24-hour esophageal pH monitoring in 285 asymptomatic infants 0-15 months old. Journal of Pediatric Gastroenterology and Nutrition. 1987; 6(2):220-224.
  4. Thach, BT. Reflux associated apnea in infants: Evidence for a laryngeal chemoreflex. The American Journal of Medicine. 1997; 103(5A): 120S-124S.
  5. Gastroesophageal reflux in neonates

  6. Jadcherla, SR. Gastroesophageal reflux in the neonate. Clinics in Perinatology. 2002; 29(1):135-158.
  7. Newell, SJ, Booth, IW, Morgan, MEI, et.al. Gastro-oesophageal reflux in preterm infants. Archives of Disease in Childhood, 1989;64:780-786.
  8. Marino, AJ, Assing, E, Carbone, MT, et.al. The incidence of gastroesophgeal reflux in preterm infants. Journal of Perinatology. 1995; 15(5):369-371.
  9. Kimball, AL, Carlton, DP. Gastroesophgeal reflux medications in the treatment of apnea in premature infants. The Journal of Pediatrics. 2001;138(3): 355-360.
  10. Page, M, Jeffery, H. The role of gastro-oesophgeal reflux in the aetiology of SIDS. Early Human Development. 2000; 59:127-149.
  11. Barrington, KJ, Tan, K, Rich, W. Apnea at discharge and gastro-esophgeal reflux in the preterm infant. Journal of Perinatology. 2002; 22:8-11.
  12.  

    Respiratory and supraesophageal manifestations of gastroesophageal reflux

  13. Menon, AP, Schefft, GL, Thach, BT. Apnea associated with regurgitation in infants. The Journal of Pediatrics. 1985; 106(4):625-629.
  14. Orlando, R. Mechanisms of reflux-induced epithelial injuries in the esophagus. The American Journal of Medicine. 2000; 108(4A):104S-107S.
  15. Richter, JE. Gastroesophgeal reflux disease and asthma: The two are directly related. The American Journal of Medicine. 2000; 108(4A):153S-158S.
  16. Holloway, RH. Esophageal body motor response to reflux events: Secondary peristalsis. The American Journal of Medicine. 2000; 108(4A):20S-26S.
  17. Peter, CS, Sprodowski, N, Bohnhorst, B, et.al. Gastroesophageal reflux and apnea of prematurity: No temporal relationship. Pediatrics. 2002; 109(1): 8-11.
  18. Ethics

  19. FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting. (www.fda.gov/cder/pediatric/ethics-statement.htm) (accessed 4/29/02).
  20. FDA Pediatric Ethics Working Group Consensus Statement on Pediatric Advisory Subcommittee’s September 11, 2000 Meeting. (www.fda.gov/cder/pediatric/ethics-statement.htm). (accessed 4/29/02).
  21. Special study designs: Randomized-withdrawal trials

  22. Temple, RJ. Special study designs: Early escape, enrichment, studies in non-responders. Commun. Statist. Theory Meth. 1994; 23(2):499-531.
  23. Choice of control group in clinical studies

  24. Guidance For Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials. Food and Drug Administration. May 2001.
  25. Temple, R, Ellenberg, S. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. .Annals of Internal Medicine. 2000; 133(6):455-463.
  26. Ellenberg, S, Temple, R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Interanl Medicine. 2000; 133(6): 464-475.
  27. Temple, RJ. When are clinical trials of a given agent vs. placebo no longer appropriate or feasible? Controlled Clinical Trials. 1997; 18:613-620
  28. Pharmacology of proton-pump inhibitors

  29. James, LP. Pharmacology for the gastrointestinal tract. Clinics in Perinatology. 2002; 29(1):115-133.
  30. Wolfe, MM, Sachs, G. Acid suppression: Optimizing therapy for gastroduodenal ulcer healing, gastroesophageal reflux disease, and stress-related erosive syndrome. Gastroenterology. 2000; 118:S9-S31.
  31. Richardson, et.al. Proton pump inhibitors in GI disorders. Drugs. 1998; 56(3):308-334.
  32. Sachs, G, Shin, JM, Briving, C, et.al. The pharmacology of the gastric acid pump: The H+, K+ ATPase. Annual Review of Pharmacology and Toxicology. 1995; 33:277-305.