The comparison of the efficacy of omeprazole with lansoprazole in the recovery rate of neonatal gastro esophageal reflux disease refractory to conservative therapy

The comparison of the efficacy of omeprazole with lansoprazole in the treatment of GERD in term neonates refractory to conservative therapy.

A randomized double blinded clinical trial with two arm parallel groups and simple randomization at the individual level and using random number table with allocation concealment by sequentially numbered sealed opaque envelop.

The study will be performed on 120 term neonates with the diagnosis of gastro esophageal reflux disease attending to Bahrami Hospital. Eligible neonates will be randomly assigned to two groups receiving either omeprazole or lansoprazole. The physician and other caregivers, the researcher who collects the data and the person who analyses the data are blind to the study.

Major Inclusion Criteria: Study subjects will include term neonates aged 1-30 days with symptoms and signs of GERD not responding to conservative therapies including anti-reflux positioning, milk thickening and hypo-allergen regimen. Major Exclusion Criteria:1-Neonates with any underlying diseases, including anomalies or gastrointestinal obstruction, neurological diseases, sepsis, NEC, etc. 2- Using any sedative , relaxant or anticonvulsive medications .3- History of ventilation therapy

Neonates who meet the criteria will be randomly assigned to two groups to receive either omeprazole with 0 .5 mg/ kg / dose two times per day or lansoprazole 0 .5 mg/ kg / dose two times per day for one month.

Primary outcome variable includes: The recovery rate in signs and symptoms of GERD. Secondary outcome variable includes: Complications of omeprazole and lansoprazole in each group.

We used the random number tables from ''Rand Company'' for simple randomization that include random numbers composed of five digits and are printed in blocks of five rows . We chose a starting page in the random number table and dropped a pencil anywhere on the page to indicate a starting block in the table with eyes closed . After starting place was identified, we recorded the first three digits as we used coding system from 001 to108 for number 1 to number 108 of the patients . After that we recorded each three next digits with moving the pencil going down the column to the bottom of the page and then to the top of the next column , and so on till 108 numbers were chosen. We ignored duplicates and omitted the “ three digits “ numbers more than 108. The random numbers for coding numbers from 001 to 054 were considered as group A and the random numbers for coding numbers from 055 to108 considered as group B. According to the sample size of the study , opaque envelopes and cards were provided . Each random number was written on one opaque envelope and each card was put in one opaque envelope according to group A and B. Then the opaque envelopes were sealed and dropped into a box . According to the entrance of each participant, one of the sequentially numbered sealed envelope was opened and the group of intervention was defined.

The participants, the medical clinician, the researcher who collect data and the who analyze the data are blind.