Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT00855361
Eligibility Criteria:
Inclusion Criteria:
* Patients must need a feeding tube in place for enteral alimentation (complete or partial) and be in a neonatal intensive care unit or step down unit
* Patients participating in the pHmetry assessment must be in need of this assessment
* New born, neonate or pre-term infants less than 44 weeks with a minimum weight of 0.8 kg and with a presumptive diagnosis of GERD
* Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2-blockers or antacids
* Patients should be generally healthy, other than for the presence of GERD.
Exclusion Criteria:
* A history of or current clinically significant medical illness (excluding GERD, asthma, reactive airway disease or cystic fibrosis-dependant GERD)
* Continuous drip tube feeding with formula or breast milk
* Patients whose mothers are taking PPIs and who are pumping breast milk to be fed to their infants
* Continuous positive airway pressure (CPAP) delivered via nasal prong or oral mask
* Serum concentrations of hepatic transaminases \> 3-fold higher than the upper limit of normal for age creatinine values = 106 micromoles/L
* Clinically relevant abnormal laboratory values
* Treatment with full therapeutic doses of sucralfate or any medication that affects gastrointestinal motility such as baclofen, erythromycin, metoclopramide, cisapride, or domperidone
* A history of allergy or sensitivity to PPIs or to their inactive ingredients
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
44 Weeks
Study:
NCT00855361
Study Brief:
Protocol Section:
NCT00855361