PMID- 36310566 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20221102 IS - 2772-5723 (Electronic) IS - 2772-5723 (Linking) VI - 1 IP - 5 DP - 2022 TI - Symptom Scores and pH-Impedance: Secondary Analysis of a Randomized Controlled Trial in Infants Treated for Gastroesophageal Reflux. PG - 869-881 LID - 10.1016/j.gastha.2022.06.004 [doi] AB - BACKGROUND AND AIMS: To evaluate and compare gastro-esophageal 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. FAU - Sultana, Zakia AU - Sultana Z AD - Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio. AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. FAU - Hasenstab, Kathryn A AU - Hasenstab KA AD - Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio. AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. FAU - Moore, Rebecca K AU - Moore RK AD - Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio. AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. FAU - Osborn, Erika K AU - Osborn EK AD - Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio. AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. AD - Department of Neonatology, Nationwide Children's Hospital, Columbus, Ohio. FAU - Yildiz, Vedat O AU - Yildiz VO AD - Biostatistics Resource at Nationwide Children's Hospital, (BRANCH), Columbus, Ohio. AD - Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University College of Medicine, Columbus, Ohio. FAU - Wei, Lai AU - Wei L AD - Biostatistics Resource at Nationwide Children's Hospital, (BRANCH), Columbus, Ohio. AD - Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University College of Medicine, Columbus, Ohio. FAU - Slaughter, Jonathan L AU - Slaughter JL AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. AD - Department of Neonatology, Nationwide Children's Hospital, Columbus, Ohio. AD - Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio. FAU - Jadcherla, Sudarshan R AU - Jadcherla SR AD - Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio. AD - Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio. AD - Department of Neonatology, Nationwide Children's Hospital, Columbus, Ohio. AD - Division of Pediatric Gastroenterology, Department of Pediatrics, Hepatology, and Nutrition, The Ohio State University College of Medicine, Columbus, Ohio. LA - eng SI - ClinicalTrials.gov/NCT02486263 GR - R01 DK068158/DK/NIDDK NIH HHS/United States PT - Journal Article DEP - 20220620 PL - Netherlands TA - Gastro Hep Adv JT - Gastro hep advances JID - 9918350485906676 PMC - PMC9615096 MID - NIHMS1836606 OTO - NOTNLM OT - Gastroesophageal Reflux Disease OT - Infant OT - Proton Pump Inhibitor OT - Symptom Questionnaire OT - pH-Impedance COIS- Conflicts of Interest: The authors disclose no conflicts. EDAT- 2022/11/01 06:00 MHDA- 2022/11/01 06:01 PMCR- 2022/10/28 CRDT- 2022/10/31 04:04 PHST- 2022/10/31 04:04 [entrez] PHST- 2022/11/01 06:00 [pubmed] PHST- 2022/11/01 06:01 [medline] PHST- 2022/10/28 00:00 [pmc-release] AID - 10.1016/j.gastha.2022.06.004 [doi] PST - ppublish SO - Gastro Hep Adv. 2022;1(5):869-881. doi: 10.1016/j.gastha.2022.06.004. Epub 2022 Jun 20.