Assessment of inflammatory response of bronchial cells to gastric juice from hospitalized infants on and off proton pump inhibitor (PPI) therapy, PICU admitted children and long term users (0-18 years) of PPIs and controls off PPI

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Group 1 - Hospitalized infants
- Informed consent signed by care-givers
- Age ><=34 weeks GA to 6 months
- Admitted for reasons other than structural gastrointestinal disorders and where no suspicion of such an abnormality exist
- Tube fed
- Appointed to be treated with PPIs or no signs of GER related symptoms or aspiration risk and thus unlikely to receive PPI in the near future.;Group 2 - PICU admitted children
- Informed consent signed by care-givers or patient if aged *12 years
- Age ><=34 weeks GA to 18 years
- Admitted for reasons other than structural gastrointestinal disorders and where no suspicion of such an abnormality exist
- Tube fed
- Mechanically ventilated
- Appointed to be treated with PPIs ;Group 3 * outpatient clinic children
- Informed consent signed by care-givers or patient if aged *12 years
- Age ><=34 weeks GA to 18 years
- who have received and currently receive PPI treatment for at least six weeks because of suspected GERD or NO anti-relfux therapy
- Appointed for intraesophageal evaluation of PPI treatment (eg. pHmetry, endoscopy, manometry) or having a permanent nasogastric/PEG tube

Exclusion Criteria

- > 6 months (Group 1)
- Prematurity < 34 weeks GA at birth
- Previous gastro-intestinal (GI) surgery
- Structural GI abnormalities (exception group 3)
- Infectious gastro-enteritis
- Use of medications other than PPIs possibly influencing gastric conditions and/or GI motility
- Syndromes (exception group 3)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* IL-8 production in two cell cultures (cultivated bronchial and childs<br /><br>obtained bronchial cell cultures) exposed to gastric juice from three patients<br /><br>groups (hospitalized infants, PICU admitted children and long term PPI users.<br /><br> Determine relation between IL8 production of bronchial cells and<br /><br>endotoxine/bile acid/pepsin/acidity levels in GJ from patients in all study<br /><br>groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Determine the composure (pH, concentrations of bile acid, pepsin and<br /><br>endotoxine) of GJ in:<br /><br>- Hospitalized infants,on and off PPI, before and during PPI treatment, before<br /><br>and after feed.<br /><br>- children admitted to the pediatric intensive care unit (PICU) before and<br /><br>during PPI treatment.<br /><br>- Children who have received and currently receive PPI treatment for at least<br /><br>six weeks.<br /><br>* Determine whether there is a difference in inflammatory reaction of bronchial<br /><br>cells and GJ composure between breast milk fed and formula fed hospitalized<br /><br>infants<br /><br>* Measuring cytotoxic effect of GJ solutions on all cell cultures </p><br>