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

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 - Bronchial inflammation to gastric juice from children on and off PPI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39158

Enrollment

Registered

2012-07-12

Start date

2013-01-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux/heartburn - microaspiration induced respiratory tract infections/airway infections due to reflux in airway

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Group 1 - Hospitalized infants - Informed consent signed by care-givers - Age >

Exclusion criteria

Exclusion criteria: - > 6 months (Group 1) - Prematurity

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results