Clinical trial with thickened feeding for treatment of regurgitation in infants

This document serves as an update of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) 2009 clinical guidelines for the diagnosis and management of gastroesophageal reflux disease (GERD) in infants and children and is intended to be applied in daily practice and as a basis for clinical trials. Eight clinical questions addressing diagnostic, therapeutic and prognostic topics were formulated. A systematic literature search was performed from October 1, 2008 (if the question was addressed by 2009 guidelines) or from inception to June 1, 2015 using Embase, MEDLINE, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Clinical Trials. The approach of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was applied to define and prioritize outcomes. For therapeutic questions, the quality of evidence was also assessed using GRADE. Grading the quality of evidence for other questions was performed according to the Quality Assessment of Studies of Diagnostic Accuracy (QUADAS) and Quality in Prognostic Studies (QUIPS) tools. During a 3-day consensus meeting, all recommendations were discussed and finalized. In cases where no randomized controlled trials (RCT; therapeutic questions) or diagnostic accuracy studies were available to support the recommendations, expert opinion was used. The group members voted on each recommendation, using the nominal voting technique. With this approach, recommendations regarding evaluation and management of infants and children with GERD to standardize and improve quality of care were formulated. Additionally, 2 algorithms were developed, 1 for infants <12 months of age and the other for older infants and children.

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“…as determined by predefined outcome measures and/or occurrence of side-effects and adverse events),. (158, 159, 162–165, 167, 168)…”

Section: Question 4: What Non-pharmacologic Treatment Options Are Effmentioning

confidence: 99%

Pediatric Gastroesophageal Reflux Clinical Practice Guidelines

Rosen

Vandenplas

Singendonk

et al. 2018

J. pediatr. gastroenterol. nutr.

898

805

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“…Depending on the nature of the thickening agent, the impact on the stool frequency and consistency can differ. For example with a formula thickened with locust bean, Iacono et al [ 9 ] reported diarrhea to occur in 16.7% (14/84) of infants. Although the new formula is thickened with fibres and even though four children have left the study before day 14 due to loose stools, this formula seems to have a regulatory effect on stool composition.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical efficacy on regurgitation of AR formulas thickened with locust bean has been demonstrated in several clinical trials [ 6 7 8 ]. However, infants fed with such formulas may have softer and more frequent stools than those fed with starch-thickened formulas [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Tolerance of a New Anti-Regurgitation Formula

Dupont

Vandenplas

2016

Pediatr Gastroenterol Hepatol Nutr

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PurposeRegurgitation is a common physiological phenomenon in infants. The aim of the present study was to evaluate the efficacy of a new anti-regurgitation (AR) formula (Novalac), thickened with an innovative complex including fibres, on the daily number of regurgitations and to assess its impact on stool consistency and frequency.MethodsInfants younger than five months, presenting at least 5 regurgitations per day were recruited in this trial. The efficacy of the new formula on regurgitation (daily number and Vandenplas score), stool frequency and consistency were assessed at day 14 and 90. Growth data were recorded at each study visit.ResultsNinety babies (mean age 9.6±5.8 weeks) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was 7.3±3.4. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly (-6.3±3.3, p<0.001) including in those previously fed a thickened formula (-6.2±3.0, p<0.001). There was no significant change in stool consistency at day 14. After 3 months, 97.5% of infants had formed or soft stools. Growth was appropriate with a slight increase of weight-for-age z-score (from -0.5±1.0 to -0.1±0.9) and no change of weight-for length z-score (-0.1±1.1 to -0.1±-1.1).ConclusionThe new AR formula thickened with an innovative complex is very effective in reducing the daily number of regurgitations without having a negative impact on stools consistency.

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“…Despite thickened feeds are currently increasingly being used to treat infants with GER [56], it has been debated that thickened formula increases the caloric intake, thus predisposing infants to later obesity [51,53,[56][57][58]. Conversely, infants fed with formula thickened with carob bean gum were reported having a comparable weight increase to the control group [54]. Similar results were with a soy fiber-thickened formula [58].…”

Section: Feeding Changes In Infantsmentioning

confidence: 92%

“…The primary outcome was assessed through multichannel intraluminal impedance, reporting a significant decrease of only acid reflux episodes, while apneic episodes and non-acid GER indexes were not significantly altered [49][50][51]. The efficacy of thickened formula was demonstrated both on typical and atypical reflux symptoms [52][53][54][55]. Despite thickened feeds are currently increasingly being used to treat infants with GER [56], it has been debated that thickened formula increases the caloric intake, thus predisposing infants to later obesity [51,53,[56][57][58].…”

Section: Feeding Changes In Infantsmentioning

confidence: 99%

Clinical Picture of Gastroesophageal Reflux Disease in Children

Quitadamo¹,

Staiano²

2019

Gastroesophageal Reflux Disease - Theory and Research

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Gastroesophageal reflux (GER), defined as the passage of gastric contents into the esophagus, is a normal physiologic process occurring several times per day in healthy infants, children, and adults. The majority of GER episodes occur in the postprandial period, last in <3 min, and cause few or no symptoms. Conversely, when the reflux of gastric contents into the esophagus causes troublesome symptoms and/or complications, we talk about "gastroesophageal reflux disease (GERD)." Distinguishing physiologic GER from GERD may often be tricky for clinicians, especially in infants. The typical presentation of GERD includes the following symptoms: recurrent regurgitation, vomiting, weight loss or poor weight gain, excessive crying and irritability in infants, heartburn or chest pain, ruminative behavior, hematemesis, and dysphagia. Besides these esophageal symptoms, there is a set of extra-esophageal symptoms, mainly respiratory, which may occur along with typical symptoms or may represent the only clinical picture of GERD: odynophagia, wheezing, stridor, cough, hoarseness, dental erosions, and apnea/apparent life-threatening events (ALTEs). While infantile GER tends to resolve spontaneously and does not deserve pharmacological treatment, GERD management includes lifestyle changes, pharmacologic therapy, and surgery. Therefore, a proper diagnosis of these two conditions, besides other possible conditions mimicking reflux, is crucial in order to target the treatment, avoiding the overuse of antacid drugs that currently represents a major source of concern.

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Clinical trial with thickened feeding for treatment of regurgitation in infants

Cited by 21 publications

References 3 publications

Pediatric Gastroesophageal Reflux Clinical Practice Guidelines

Pediatric Gastroesophageal Reflux Clinical Practice Guidelines

Efficacy and Tolerance of a New Anti-Regurgitation Formula

Clinical Picture of Gastroesophageal Reflux Disease in Children

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