Acid Reflux Clinical Trial
Official title:
In Infants With Symptoms of Tracheomalacia or Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms? A Randomized, Controlled Trial
Verified date | November 2017 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
All neonates, ages 0 to 4 months, presenting to LPCH pediatric ENT clinic for airway
difficulties or stridor will be screened for inclusion. As is consistent with an acceptable
standard of medical care, these children will undergo a flexible nasal endoscopic exam to
make the diagnosis of laryngomalacia, as well as be weighed and a breastfeeding history
taken. If laryngomalacia is present, the study staff with then administer the Infant
Gastroesophageal Reflux Questionnaire (IGERQ) and an airway symptoms questionnaire (ASQ).
Those babies with an IGERQ score of less than sixteen (no more than mild reflux) and an ASQ
score greater than six will be eligible for randomization. The patient will then be randomly
placed in the control group (placebo) or the intervention group (ranitidine 2mg/kg every 12
hours or famotidine 0.5 mg/kg daily). Patients will stay on medication for a minimum of 6
months, or until symptoms resolve. Patients will be seen in follow up at 1, 2, 3, 4, 5, 6, 8
and 10 months. At which time I-GERQ, ASQ and weights will be taken. The primary outcome
measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine
versus placebo.
A secondary outcome will be weight gain in percentile. If the patient's I-GERQ score goes
above 16 at any time in the study, the patient will be crossed over to the treatment arm and
started on medical treatment.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility |
Inclusion Criteria: - age 0 - 4 months old - stridor and flexible laryngoscopy demonstrating laryngomalacia - airway symptom score over 4 - only has physiologic GER (I-GERQ < 16) Exclusion Criteria: - requiring surgery for LGM - other airway dz seen on flexible laryngoscopy - history of or already on PPI therapy - minimal/mild airway symptoms (airway score < 4) - pathologic GERD (I-GERQ greater than 16) - These pts cannot be randomized because this is the standard score in Pediatric GI literature strongly indicating anti-reflux meds - premature birth (< 36 weeks) |
Country | Name | City | State |
---|---|---|---|
United States | Lucile Packard Children's Hospital Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Olney DR, Greinwald JH Jr, Smith RJ, Bauman NM. Laryngomalacia and its treatment. Laryngoscope. 1999 Nov;109(11):1770-5. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to normalization of airway symptoms score | The primary outcome measure will be the time for the ASQ score to drop to normal on ranitidine or famotidine versus placebo. | 10 months | |
Secondary | Weight gain | A secondary outcome will be weight gain in percentile. | 10 month |
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