Dataset Information

The Effect of Alginate in Gastroesophageal Reflux in Infants.

ABSTRACT:

Background

Guidelines are contradictory regarding the use of alginate in infants with persisting gastroesophageal reflux (GER). While The British National Institute for Health and Care (NICE) guidelines consider alginate as a treatment option, the guidelines of the European and North-American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN, NASPGHAN) do not recommend alginates.

Aims

We assessed the efficacy of alginate to reduce GER episodes in infants.

Methods

In a prospective, observational study, we consecutively enrolled all infants referred for pH-multiple intraluminal impedance (pH-MII) recording because of persisting GER symptoms not responsive to behavior and dietetic modifications. A 48-h pH-MII was performed in all infants; a baseline recording was performed during the first 24 h while magnesium or sodium alginate was administered during the second 24 h. The primary endpoint was the difference in the total number of GER episodes per 24 h between the baseline day and the second day during which the alginate was administered. The secondary outcome was the difference in symptoms between each period. We also compared other pH-MII data from before and during alginate administration.

Results

We recruited 43 infants (median age 68 days, range 25-306); three pH-MII tracings were excluded because of artifacts. The median number of all MII reflux episodes was significantly reduced during alginate administration (76.0 vs 69.5; p??10% during the alginate period in 31/40 infants (77.5%), without a significant difference between magnesium and sodium alginate.

Conclusion

These results suggest that alginate significantly decreases the number and extension of both acid and non-acid reflux episodes and associated symptoms in infants.

SUBMITTER: Salvatore S

PROVIDER: S-EPMC6267531 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

The Effect of Alginate in Gastroesophageal Reflux in Infants.

Salvatore Silvia S Ripepi Antonio A Huysentruyt Koen K van de Maele Kristel K Nosetti Luana L Agosti Massimo M Salvatoni Alessandro A Vandenplas Yvan Y

Paediatric drugs 20181201 6

<h4>Background</h4>Guidelines are contradictory regarding the use of alginate in infants with persisting gastroesophageal reflux (GER). While The British National Institute for Health and Care (NICE) guidelines consider alginate as a treatment option, the guidelines of the European and North-American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN, NASPGHAN) do not recommend alginates.<h4>Aims</h4>We assessed the efficacy of alginate to reduce GER episodes in infants. ...[more]

PMID: 30182358

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Project description:Background and objectiveOmeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.MethodsInfants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.ResultsSeventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.ConclusionsA single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.Clinical trial registerClinicalTrials.gov Identifier: NCT00226044.

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Dataset Information

The Effect of Alginate in Gastroesophageal Reflux in Infants.

Background

Aims

Methods

Results

Conclusion

Publications

The Effect of Alginate in Gastroesophageal Reflux in Infants.

Similar Datasets

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