Lansoprazole in Preterm Infants With Reflux

Preterm Infants Clinical Trial

Official title:

A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778101
• Other study ID #: Lanso_pilot
• Secondary ID: 0720120860
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2013
• Last updated: September 11, 2013
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: September 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

• preterm infant

• documented gastrointestinal reflux by 24hr pH monitoring

Exclusion Criteria:

• unstable vital sings

• congenital anomaly in upper gastrointestinal tract incuding esophagus

• drug history of H2 blocker during last 1 week

• medication of warfarin, carbamazepine, phenytoin, rifampin

• renal or hepatic dysfunction

• inappropriate clinical conditions judged by researchers

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastrointestinal Reflux
• Premature Birth
• Preterm Infants

Intervention

Drug:
• Lansoprazole
lansoprazole 1mg/kg twice a day for 14days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Symtomts of reflux_d5	apnea bradycardia desaturation regurgitate vomiting	day 5	No
Secondary	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	day10	No
Secondary	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	No
Secondary	Symtomts of reflux_d10	apnea bradycardia desaturation regurgitate vomiting	day 10	No
Secondary	Symtomts of reflux_d14	apnea bradycardia desaturation regurgitate vomiting	Symtomts of reflux_d14 day 14	No