Laryngomalacia Study

Laryngomalacia Clinical Trial

Official title:

Improving Care For Infants With Laryngomalacia: A Pilot Randomized Controlled Trial of Omeprazole Versus Placebo

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01782560
• Other study ID #: H12-03495
• Status: Withdrawn
• Phase: Phase 1
• First received: January 17, 2013
• Last updated: July 28, 2015
• Start date: February 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Children's & Women's Health Centre of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Noisy breathing is commonly caused by a floppy voicebox which is a condition called laryngomalacia. The cause of laryngomalacia is not fully understood, but some studies have suggested that it could be due to acid escaping from the stomach and spreading up the swallowing passage to the throat (acid reflux). This affects about 1 in 100 newborns and is therefore one of the most common reasons for infants to see Otolaryngologists at BC Children's Hospital (BCCH). These infants can have a spectrum of distressing symptoms including squeaky breathing, choking, difficulty feeding, failure to gain weight, and episodes of turning blue (due to lack of oxygen).

At present, Otolaryngologists at BCCH will sometimes give children with laryngomalacia medication to reduce the amount of acid they make in their stomachs, in the hope that this will reduce their symptoms of laryngomalacia. It has never been scientifically confirmed whether anti-reflux medication will benefit these children any more than doing nothing at all.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• children less than 1 years old

• children determined that they have laryngomalacia at the Pediatric Otolaryngology clinic at BC Children's Hospital.

Exclusion Criteria:Children cannot participate in this study if they have:

• those already on anti-reflux medicine and considered medically unsafe to go through the washout period;

• allergy to the trial medications;

• nasogastric or permanent feeding tube;

• other laryngeal abnormalities.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngomalacia

Intervention

Drug:
• Omeprazole
Omeprazole (a proton-pump inhibitor) is the most common treatment given to infants with laryngomalacia, in the hope that this will reduce their symptoms. Although this is an effective anti-reflux medication in this population, its use is off-label, and like any medication has potential risks, particularly in very young children. Side effects that have been described include abdominal pain, diarrhea, constipation, and cough. Although omeprazole is usually a safe medication, we do not currently know if it provides any benefit in laryngomalacia.
• Placebo

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's & Women's Health Centre of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (18)

Belafsky PC, Postma GN, Koufman JA. The validity and reliability of the reflux finding score (RFS). Laryngoscope. 2001 Aug;111(8):1313-7. — View Citation

Fan LL, Flynn JW. Laryngoscopy in neonates and infants: experience with the flexible fiberoptic bronchoscope. Laryngoscope. 1981 Mar;91(3):451-6. — View Citation

Giannoni C, Sulek M, Friedman EM, Duncan NO 3rd. Gastroesophageal reflux association with laryngomalacia: a prospective study. Int J Pediatr Otorhinolaryngol. 1998 Feb;43(1):11-20. — View Citation

Hartl TT, Chadha NK. A systematic review of laryngomalacia and acid reflux. Otolaryngol Head Neck Surg. 2012 Oct;147(4):619-26. Epub 2012 Jun 27. Review. — View Citation

Higginbotham TW. Effectiveness and safety of proton pump inhibitors in infantile gastroesophageal reflux disease. Ann Pharmacother. 2010 Mar;44(3):572-6. doi: 10.1345/aph.1M519. Epub 2010 Feb 2. Review. — View Citation

Kleinman L, Rothman M, Strauss R, Orenstein SR, Nelson S, Vandenplas Y, Cucchiara S, Revicki DA. The infant gastroesophageal reflux questionnaire revised: development and validation as an evaluative instrument. Clin Gastroenterol Hepatol. 2006 May;4(5):588-96. — View Citation

Lee KS, Chen BN, Yang CC, Chen YC. CO2 laser supraglottoplasty for severe laryngomalacia: a study of symptomatic improvement. Int J Pediatr Otorhinolaryngol. 2007 Jun;71(6):889-95. Epub 2007 Apr 9. — View Citation

Little JP, Matthews BL, Glock MS, Koufman JA, Reboussin DM, Loughlin CJ, McGuirt WF Jr. Extraesophageal pediatric reflux: 24-hour double-probe pH monitoring of 222 children. Ann Otol Rhinol Laryngol Suppl. 1997 Jul;169:1-16. — View Citation

Matthews BL, Little JP, Mcguirt WF Jr, Koufman JA. Reflux in infants with laryngomalacia: results of 24-hour double-probe pH monitoring. Otolaryngol Head Neck Surg. 1999 Jun;120(6):860-4. — View Citation

Milczuk HA, Johnson SM. Effect on families and caregivers of caring for a child with laryngomalacia. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):348-54. — View Citation

Nussbaum E. Flexible fiberoptic bronchoscopy and laryngoscopy in children under 2 years of age: diagnostic and therapeutic applications of a new pediatric flexible fiberoptic bronchoscope. Crit Care Med. 1982 Nov;10(11):770-2. — View Citation

Olney DR, Greinwald JH Jr, Smith RJ, Bauman NM. Laryngomalacia and its treatment. Laryngoscope. 1999 Nov;109(11):1770-5. — View Citation

Pontes P, Tiago R. Diagnosis and management of laryngopharyngeal reflux disease. Curr Opin Otolaryngol Head Neck Surg. 2006 Jun;14(3):138-42. Review. — View Citation

Stavroulaki P. Diagnostic and management problems of laryngopharyngeal reflux disease in children. Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):579-90. Epub 2005 Dec 15. Review. — View Citation

Thompson DM. Abnormal sensorimotor integrative function of the larynx in congenital laryngomalacia: a new theory of etiology. Laryngoscope. 2007 Jun;117(6 Pt 2 Suppl 114):1-33. — View Citation

Thompson DM. Laryngomalacia: factors that influence disease severity and outcomes of management. Curr Opin Otolaryngol Head Neck Surg. 2010 Dec;18(6):564-70. doi: 10.1097/MOO.0b013e3283405e48. Review. — View Citation

Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG, North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr. 2009 Oct;49(4):498-547. doi: 10.1097/MPG.0b013e3181b7f563. — View Citation

Zoumalan R, Maddalozzo J, Holinger LD. Etiology of stridor in infants. Ann Otol Rhinol Laryngol. 2007 May;116(5):329-34. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laryngomalacia Symptom Score	This score is a disease-specific quality of life measure for laryngomalacia. Each of the symptoms that can occur in laryngomalacia are scored as present (1) or absent (0) as follows - inspiratory stridor, suprasternal retraction, substernal retraction, feeding difficulty, choking, post-feeding vomit, failure to thrive (i.e. poor weight gain with deviation from the normal growth curve), and cyanosis. Therefore for each patient, a total symptom score is calculated (8 = all symptoms, 0 = no symptoms).	Change from baseline and at end of study (baseline and 8 weeks)	No
Secondary	Caring For a Child with Laryngomalacia Family Impact Questionnaire		Change from baseline and at end of study (baseline and 8 weeks)	No
Secondary	Revised Infant Gastro-Esophageal Reflux Questionnaire		Change from baseline and at end of study (baseline and 8 weeks)	No
Secondary	Reflux Finding Score		Change from baseline and at end of study (baseline and 8 weeks)	No
Secondary	End of treatment 24-hour double-probe pH monitoring		Change from baseline and at end of study (baseline and 8 weeks)	No
Secondary	Weight		Change from baseline, to half-way point and at end of study (baseline, 4 weeks and 8 weeks)	No