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| ID | Type | Description | Link |
|---|---|---|---|
| 0720120860 | Other Grant/Funding Number | Konect |
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This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lansoprazole | Experimental | lansoprazole 1mg/kg twice a day for 14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | lansoprazole 1mg/kg twice a day for 14days |
|
| Measure | Description | Time Frame |
|---|---|---|
| impedance pH monitoring | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability | day14 |
| Measure | Description | Time Frame |
|---|---|---|
| Symtomts of reflux_d5 | apnea bradycardia desaturation regurgitate vomiting | day 5 |
| impedance pH monitoring_d10 | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Suk Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | 110-740 | South Korea |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| day10 |
| impedance pH monitoring_d5 | number of acid exposure percent time of acid exposure mean acid clearance time Acid Reflux Composite Score Analysis ; total time in reflux, episodes of 5min, composite score Bolus exposure(impedance); acid percent time, weakly acid percent time, weakly alkaline percentime Reflux Episodes activity Reflux Symptom Index Reflux Symptom Sensitivity Index Reflux Symptom Association Probability | day5 |
| Symtomts of reflux_d10 | apnea bradycardia desaturation regurgitate vomiting | day 10 |
| Symtomts of reflux_d14 | apnea bradycardia desaturation regurgitate vomiting | Symtomts of reflux_d14 day 14 |
| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |