Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial
Background: Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back and sl...
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doaj-10e542939f5543b08e761393e15933422020-11-25T03:26:58ZengHygeia Press di Corridori MarinellaJournal of Pediatric and Neonatal Individualized Medicine2281-06922018-05-0172e070201e07020110.7363/070201439Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trialPeymaneh Alizadeh Taheri0Fatemeh Mahdianzadeh1Mamak Shariat2Manelie Sadeghi3Tehran University of Medical Sciences, Bahrami Children Hospital, Tehran, IranTehran University of Medical Sciences, Bahrami Children Hospital, Tehran, IranMaternal-Fetal & Neonatal Research Center, Tehran University of Medical Sciences, Tehran, IranTehran University of Medical Sciences, Research Development Center of Bahrami Children Hospital, Tehran, IranBackground: Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back and sleep disturbance. Aims: As no study has compared metoclopramide plus ranitidine with metoclopramide plus omeprazole in the management of neonatal GERD resistant to conservative and monotherapy, this study was carried out. Study design: This study was a randomized clinical trial of term neonates with GERD resistant to conservative and monotherapy admitted to the neonatal ward of Bahrami Children Hospital during 2013-2015. Totally, 116 term neonates (mean age 10.53 ± 8.17 days; girls 50.9%) were randomly assigned to a double blind trial with either oral omeprazole plus metoclopramide (group A) or oral ranitidine plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month. Results: There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “omeprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” (93.74% ± 7.28% vs. 75.43% ± 23.24%, p = 0.028). All clinical manifestations recovered significantly in group A while the response rate of irritability and wheezing was not significant in group B (primary outcome). There were no side effects in either group after one week and one month of treatment (secondary outcome). Conclusions: The response rate was > 70% in each group, but it was significantly higher in group A (> 90%). Combination of each acid suppressant with metoclopramide led to higher response rate in comparison with monotherapy used before intervention.https://www.jpnim.com/index.php/jpnim/article/view/527gastroesophageal reflux diseaseneonatesranitidineomeprazolemetoclopramidecombined therapy |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Peymaneh Alizadeh Taheri Fatemeh Mahdianzadeh Mamak Shariat Manelie Sadeghi |
spellingShingle |
Peymaneh Alizadeh Taheri Fatemeh Mahdianzadeh Mamak Shariat Manelie Sadeghi Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial Journal of Pediatric and Neonatal Individualized Medicine gastroesophageal reflux disease neonates ranitidine omeprazole metoclopramide combined therapy |
author_facet |
Peymaneh Alizadeh Taheri Fatemeh Mahdianzadeh Mamak Shariat Manelie Sadeghi |
author_sort |
Peymaneh Alizadeh Taheri |
title |
Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
title_short |
Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
title_full |
Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
title_fullStr |
Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
title_full_unstemmed |
Combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
title_sort |
combined therapy in gastro-esophageal reflux disease of term neonates resistant to conservative therapy and monotherapy: a clinical trial |
publisher |
Hygeia Press di Corridori Marinella |
series |
Journal of Pediatric and Neonatal Individualized Medicine |
issn |
2281-0692 |
publishDate |
2018-05-01 |
description |
Background: Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back and sleep disturbance.
Aims: As no study has compared metoclopramide plus ranitidine with metoclopramide plus omeprazole in the management of neonatal GERD resistant to conservative and monotherapy, this study was carried out.
Study design: This study was a randomized clinical trial of term neonates with GERD resistant to conservative and monotherapy admitted to the neonatal ward of Bahrami Children Hospital during 2013-2015. Totally, 116 term neonates (mean age 10.53 ± 8.17 days; girls 50.9%) were randomly assigned to a double blind trial with either oral omeprazole plus metoclopramide (group A) or oral ranitidine plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month.
Results: There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “omeprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” (93.74% ± 7.28% vs. 75.43% ± 23.24%, p = 0.028). All clinical manifestations recovered significantly in group A while the response rate of irritability and wheezing was not significant in group B (primary outcome). There were no side effects in either group after one week and one month of treatment (secondary outcome).
Conclusions: The response rate was > 70% in each group, but it was significantly higher in group A (> 90%). Combination of each acid suppressant with metoclopramide led to higher response rate in comparison with monotherapy used before intervention. |
topic |
gastroesophageal reflux disease neonates ranitidine omeprazole metoclopramide combined therapy |
url |
https://www.jpnim.com/index.php/jpnim/article/view/527 |
work_keys_str_mv |
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