Dataset Information

Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.

ABSTRACT: BACKGROUND AND OBJECTIVE:Omeprazole 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. METHODS:Infants (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

SUBMITTER: Bestebreurtje P

PROVIDER: S-EPMC7511285 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.

Bestebreurtje Petra P de Koning Barbara A E BAE Roeleveld Nel N Knibbe Catherijne A J CAJ Tibboel Dick D van Groen Bianca B van de Ven Cees P CP Plötz Frans B FB de Wildt Saskia N SN

European journal of drug metabolism and pharmacokinetics 20201001 5

<h4>Background and objective</h4>Omeprazole 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 dise ...[more]

PMID: 32594305

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Project description:It is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.There was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.An expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.ClinicalTrials.gov NCT01915173.

Project description:Wide variation exists in the treatment of suspected gastroesophageal reflux disease (GERD) in premature infants; it is unknown to what degree diagnosis and treatment are affected by the treating physician's medical specialty or interpretation of the medical literature.This study involved an online survey of board-certified neonatologists, pediatric pulmonologists, and pediatric gastroenterologists about their beliefs regarding the symptoms, diagnosis, and treatment of GERD in premature infants in the NICU on the basis of both clinical impression and interpretation of the literature.A total of 1021 neonatologists, 232 pediatric pulmonologists, and 222 pediatric gastroenterologists participated in the study (47.5% response rate). There was disagreement among specialists in nearly all aspects of the survey. Pulmonologists were most likely to report that respiratory symptoms are caused by GERD (P < .001). Neonatologists were least likely to report that a therapeutic trial of pharmacologic agents would be useful for diagnosing GERD (P < .001) or that lansoprazole, ranitidine, or cimetidine are safe or effective (P < .001). No pharmacologic therapy had >50% of respondents supporting its effectiveness. There was moderate correlation between physician belief based on the medical literature and belief based on clinical impression (Spearman rank correlation: 0.47-0.75). For therapies supported by multiple meta-analyses in infants versus therapies with few infant trials, physicians rated the evidence for effectiveness similarly.There is wide variation among pediatric specialists regarding beliefs about GERD in premature infants, as well as about the weight of evidence in the medical literature for this patient population. Physician beliefs do not seem to be driven by the degree of evidence in the neonatal literature. With no agreed-on standard of care in the setting of widespread use of antireflux medications, greater understanding is needed about the ways physicians form clinical impressions, access and process medical evidence, and apply it to patient care.

Project description:BackgroundGuidelines 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.AimsWe assessed the efficacy of alginate to reduce GER episodes in infants.MethodsIn 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.ResultsWe 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?<?0.001). Crying-fussiness, cough and regurgitation episodes all significantly improved during alginate administration (p = 0.00012; p = 0.005 and p = 0.04, respectively). The following MII parameters also decreased during the alginate administration: acid (19.0 vs 14.5; p?<?0.04), non-acid (52.0 vs 49.5; p?<?0.004), proximal GER episodes (46.0 vs 41.4; p?<?0.007), and bolus exposure index (1.9 vs 1.6; p?=?0.002). At least three out of seven pH-MII parameters decreased by?>?10% during the alginate period in 31/40 infants (77.5%), without a significant difference between magnesium and sodium alginate.ConclusionThese results suggest that alginate significantly decreases the number and extension of both acid and non-acid reflux episodes and associated symptoms in infants.

Dataset Information

Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.

Publications

Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.

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