Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux
Background and Aims: To evaluate and compare gastroesophageal reflux (GER) symptom scores with pH-impedance and test the effects of acid-suppressive medications with or without feeding modifications on pH-impedance in high-risk infants. Methods: Infant Gastroesophageal Reflux Questionnaire Revised (...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-01-01
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| Series: | Gastro Hep Advances |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772572322000991 |
| _version_ | 1811274036024442880 |
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| author | Zakia Sultana Kathryn A. Hasenstab Rebecca K. Moore Erika K. Osborn Vedat O. Yildiz Lai Wei Jonathan L. Slaughter Sudarshan R. Jadcherla |
| author_facet | Zakia Sultana Kathryn A. Hasenstab Rebecca K. Moore Erika K. Osborn Vedat O. Yildiz Lai Wei Jonathan L. Slaughter Sudarshan R. Jadcherla |
| author_sort | Zakia Sultana |
| collection | DOAJ |
| description | Background and Aims: To evaluate and compare gastroesophageal reflux (GER) symptom scores with pH-impedance and test the effects of acid-suppressive medications with or without feeding modifications on pH-impedance in high-risk infants. Methods: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) and 24-hour pH-impedance data were analyzed from 94 infants evaluated in a tertiary care setting for GER disease. Longitudinal data from 40 infants that received randomized GER therapy (proton pump inhibitor [PPI] with or without feeding modifications) for 4 weeks followed by 1-week washout were analyzed. Relationships between I-GERQ-R and pH-impedance metrics (acid reflux index, acid and bolus GER events, distal baseline impedance, and symptoms) were examined and effects of treatments compared. Results: (A) Correlations between I-GERQ-R and pH-impedance metrics were weak. (B) I-GERQ-R sensitivity, specificity, and positive predictive values were suboptimal when correlated with pH-impedance metrics. I-GERQ-R negative predictive value (NPV) was high for acid symptom–association probability (NPV = 84%) and distal baseline impedence (NPV = 86%) thresholds. (C) PPI with feeding modifications (vs PPI alone) did not alter pH-impedance metrics or symptom scores (P > .05); however, bolus clearance metrics worsened for both treatment groups (P < .05). Conclusions: In high-risk infants (1) I-GERQ-R may be a helpful clinical screening tool to exclude acid-GER disease diagnosis and minimize unnecessary acid-suppressive treatment, but further testing is needed for diagnosis. (2) Acid-suppressive therapy with feeding modifications has no effect on symptom scores or pH-impedance metrics. Clearance of refluxate worsened despite PPI therapy, which may signal development of pharyngoesophageal dysmotility and persistence of symptoms. (3) Placebo-controlled trials are needed in high-risk infants with objective pH-impedance criteria to determine efficacy, safety, and underlying mechanisms. Clinicaltrials.gov ID: NCT02486263. |
| first_indexed | 2024-04-12T23:10:33Z |
| format | Article |
| id | doaj.art-6fdcacbba6694b7396ff9e3c1657bcaa |
| institution | Directory Open Access Journal |
| issn | 2772-5723 |
| language | English |
| last_indexed | 2024-04-12T23:10:33Z |
| publishDate | 2022-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Gastro Hep Advances |
| spelling | doaj.art-6fdcacbba6694b7396ff9e3c1657bcaa2022-12-22T03:12:48ZengElsevierGastro Hep Advances2772-57232022-01-0115869881Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal RefluxZakia Sultana0Kathryn A. Hasenstab1Rebecca K. Moore2Erika K. Osborn3Vedat O. Yildiz4Lai Wei5Jonathan L. Slaughter6Sudarshan R. Jadcherla7Innovative Infant Feeding Disorders Research Program, Nationwide Children’s Hospital, Columbus, Ohio; Center for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, OhioInnovative Infant Feeding Disorders Research Program, Nationwide Children’s Hospital, Columbus, Ohio; Center for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, OhioInnovative Infant Feeding Disorders Research Program, Nationwide Children’s Hospital, Columbus, Ohio; Center for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, OhioInnovative Infant Feeding Disorders Research Program, Nationwide Children’s Hospital, Columbus, Ohio; Center for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, Ohio; Department of Neonatology, Nationwide Children’s Hospital, Columbus, OhioBiostatistics Resource at Nationwide Children’s Hospital (BRANCH), Nationwide Children's Hospital, Columbus, Ohio; Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University College of Medicine, Columbus, OhioBiostatistics Resource at Nationwide Children’s Hospital (BRANCH), Nationwide Children's Hospital, Columbus, Ohio; Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University College of Medicine, Columbus, OhioCenter for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, Ohio; Department of Neonatology, Nationwide Children’s Hospital, Columbus, Ohio; Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, OhioInnovative Infant Feeding Disorders Research Program, Nationwide Children’s Hospital, Columbus, Ohio; Center for Perinatal Research, The Research Institute at Nationwide Children’s Hospital, Columbus, Ohio; Department of Neonatology, Nationwide Children’s Hospital, Columbus, Ohio; Division of Pediatric Gastroenterology, Department of Pediatrics, Hepatology, and Nutrition, The Ohio State University College of Medicine, Columbus, Ohio; Correspondence: Address correspondence to: Sudarshan R. Jadcherla, MD, FRCP (Irel), DCH, AGAF, Nationwide Children's Hospital, Innovative Infant Feeding Disorders Research Program, 575 Children’s Crossroads, Columbus, Ohio 43215.Background and Aims: To evaluate and compare gastroesophageal reflux (GER) symptom scores with pH-impedance and test the effects of acid-suppressive medications with or without feeding modifications on pH-impedance in high-risk infants. Methods: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) and 24-hour pH-impedance data were analyzed from 94 infants evaluated in a tertiary care setting for GER disease. Longitudinal data from 40 infants that received randomized GER therapy (proton pump inhibitor [PPI] with or without feeding modifications) for 4 weeks followed by 1-week washout were analyzed. Relationships between I-GERQ-R and pH-impedance metrics (acid reflux index, acid and bolus GER events, distal baseline impedance, and symptoms) were examined and effects of treatments compared. Results: (A) Correlations between I-GERQ-R and pH-impedance metrics were weak. (B) I-GERQ-R sensitivity, specificity, and positive predictive values were suboptimal when correlated with pH-impedance metrics. I-GERQ-R negative predictive value (NPV) was high for acid symptom–association probability (NPV = 84%) and distal baseline impedence (NPV = 86%) thresholds. (C) PPI with feeding modifications (vs PPI alone) did not alter pH-impedance metrics or symptom scores (P > .05); however, bolus clearance metrics worsened for both treatment groups (P < .05). Conclusions: In high-risk infants (1) I-GERQ-R may be a helpful clinical screening tool to exclude acid-GER disease diagnosis and minimize unnecessary acid-suppressive treatment, but further testing is needed for diagnosis. (2) Acid-suppressive therapy with feeding modifications has no effect on symptom scores or pH-impedance metrics. Clearance of refluxate worsened despite PPI therapy, which may signal development of pharyngoesophageal dysmotility and persistence of symptoms. (3) Placebo-controlled trials are needed in high-risk infants with objective pH-impedance criteria to determine efficacy, safety, and underlying mechanisms. Clinicaltrials.gov ID: NCT02486263.http://www.sciencedirect.com/science/article/pii/S2772572322000991Gastroesophageal Reflux DiseaseSymptom QuestionnairepH-ImpedanceProton Pump InhibitorInfant |
| spellingShingle | Zakia Sultana Kathryn A. Hasenstab Rebecca K. Moore Erika K. Osborn Vedat O. Yildiz Lai Wei Jonathan L. Slaughter Sudarshan R. Jadcherla Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux Gastro Hep Advances Gastroesophageal Reflux Disease Symptom Questionnaire pH-Impedance Proton Pump Inhibitor Infant |
| title | Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux |
| title_full | Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux |
| title_fullStr | Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux |
| title_full_unstemmed | Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux |
| title_short | Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux |
| title_sort | symptom scores and ph impedance secondary analysis of a randomized controlled trial in infants treated for gastroesophageal reflux |
| topic | Gastroesophageal Reflux Disease Symptom Questionnaire pH-Impedance Proton Pump Inhibitor Infant |
| url | http://www.sciencedirect.com/science/article/pii/S2772572322000991 |
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