Infant Gastroesophageal Reflux Questionnaire Research Articles

Benefits of Massage Therapy for Infants With Symptoms of Gastroesophageal Reflux Disease

This randomized controlled pilot trial was conducted to evaluate the clinical efficacy of massage therapy (MT) for relief of symptoms of gastroesophageal reflux disease (GERD). The hypothesis was that, when compared to infants who received nonmassage therapy, infants who received MT would display fewer GERD symptoms, greater weight gain, greater amount of sleep, lower cortisol levels before and after treatment, and lower daily (area under the curve [AUC]) cortisol secretion. Participants were 36 infants born at term, 4-10 weeks of age at enrollment, healthy except for a diagnosis of GERD by their pediatrician, and with a score of at least 16 on the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R). Infants were randomized to receive either MT or a nonmassage sham treatment in their homes for 30 min twice a week for 6 weeks. Data collectors and parents were blind to study condition. GERD symptoms decreased in both groups and weight increased. Pretreatment salivary cortisol levels decreased significantly over time in the massage group while increasing in the nonmassage group. Daily cortisol level also decreased in the massage group and increased in the nonmassage group, but the difference was not significant. MT administered by a professional therapist did not affect symptoms of GERD differently than a sham treatment but did decrease infant stress as measured by cortisol. Research focusing on stress reduction in infants with GERD and multimodal treatments addressing GERD symptoms may yield the most effective treatment.

Subacute Rhinitis in Infants: Gastroesophageal Reflux Must Be Considered

The study sought to evaluate the influence of gastroesophageal reflux disease (GERD) and allergy on subacute rhinitis in infants. Mothers of 74 infants with subacute rhinitis completed the Infant Gastroesophageal Reflux Questionnaire Revised. Participants with GERD were randomized to undergo one of the following regimens for 10 days: use of fluorometholone nasal drops with positional and feeding changes; positional and feeding changes; or a placebo. The daily amount of nasal secretion decreased by 75.9% (p < 0.001), the intensity of swallowing difficulty by 79.2% (p < 0.001), and the incidence of uneasiness by 92.0% (p < 0.001) in infants treated with nasal glucocorticoid and positional and feeding changes; and the percentage differences in the amount of nasal secretion (p < 0.001), feeding difficulty (p < 0.001), and uneasiness (p < 0.001) were greater than those in the group treated with positional and feeding changes. The infants treated with placebo did not improve. The influence of nasal allergy was nonsignificant. Gastroesophageal reflux disease might contribute to aggravation of subacute rhinitis in infants.

Symptoms and Reflux in Infants: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R)—Utility for Symptom Tracking and Diagnosis

Answering a need for a thoroughly validated infant gastroesophageal reflux questionnaire, the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) was designed, refined, and validated using state-of-the-art psychometric methods. Diagnostic and evaluative (tracking) validity was identified. However, perplexing results of some clinical trials using the I-GERQ-R for diagnosis prompted analysis of possible reasons, including ambiguities in defining symptomatic gastroesophageal reflux disease (GERD) and aspects of the validation process. Symptomatic GERD is defined by "troublesomeness" of symptoms and attribution of their causation to reflux--two crucial issues. Methods of quantifying symptom-reflux associations are described and their limitations identified. The location of "symptomatic esophageal GERD" in the continuum of erosive GERD, histologic GERD, and nonerosive reflux disease is indicated, with the last including "suberosive," "premicroscopic," and "functional heartburn" subcategories. Another category is defined solely by surrogate measures of propensity to GERD (e.g., acid exposure thresholds defined on esophageal pH monitoring). During diagnostic validation of the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) instruments, asymptomatic normals were contrasted with symptomatic GERD infants (who also tested positive with esophageal histology and esophageal pH monitoring). However, the diagnostic validation did not attempt to distinguish symptomatic GERD infants from symptomatic infants without GERD. The I-GERQ-R is thus adequately sensitive to be used diagnostically to screen infants for symptom burden, but should probably be supplemented by other, perhaps invasive, testing to assure appropriate specificity. The I-GERQ-R's validation for evaluative properties, however, supports its use for tracking symptoms within clinical trials.

Gastroesophageal reflux symptoms in infants in a rural population: longitudinal data over the first six months

BackgroundIncreasing numbers of infants are receiving prescription medications for symptoms associated with gastroesophageal reflux. Our aim was to prospectively measure reported gastroesophageal reflux symptoms in healthy term infants for the first six months of life.MethodsIn a prospective cohort study in the rural Upper Peninsula of Michigan, 128 consecutive maternal-infant pairs were followed for six months and administered the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) at the one-month, two-month, four-month, and six-month well-child visits.ResultsThe I-GERQ-R scores decreased with age. Average scores were 11.74 (SE = 5.97) at one-month, 9.97(4.92) at two-months, 8.44(4.39) at four-months, and 6.97(4.05) at six months. Symptoms associated with colic were greatest at one month of age.ConclusionSymptoms of gastroesophageal reflux as measured by the I-GERQ-R decrease with age in the first six months of life in otherwise healthy infants; however the I-GERQ-R may have difficulty differentiating gastroesophageal reflux disease from colic in those under 3 months of age.

Prevalence and Natural History of Gastroesophageal Reflux: Pediatric Prospective Survey

The prevalence and natural history of gastroesophageal reflux in infants have been poorly documented. The aim of this study was to evaluate the prevalence and natural history of infant regurgitation in Italian children during the first 2 years of life. A detailed questionnaire, according to the Rome II criteria, was completed by 59 primary care pediatricians to assess infant regurgitation in consecutive patients seen in their office over a 3-month period. A total of 2642 patients aged 0 to 12 months were prospectively enrolled during this 3-month period. Follow-up was performed at 6, 12, 18, and 24 months of age. A total of 313 children (12%; 147 girls) received the diagnosis of infant regurgitation. Vomiting was present in 34 of 313 patients. Their score for the Infant Gastroesophageal Reflux Questionnaire was 8.51 +/- 4.75 (mean +/- SD). Follow-up visits were conducted to the end in 210 of 313 subjects. Regurgitation had disappeared in 56 of 210 infants by the first 6 months of age, in 128 by the first 12 months, in 23 at 18 months, and in 3 patients by the first 24 months. At follow-up, 1 of 210 patients had developed a gastroesophageal reflux disease with esophagitis, proven endoscopically and histologically; another patient received a diagnosis of cow milk protein intolerance. The Infant Gastroesophageal Reflux Questionnaire score reached 0 after 8.2 +/- 3.9 months in breastfed infants (89 of 210) and after 9.6 +/- 4.1 months in artificially fed infants. We found that 12% of Italian infants satisfied the Rome II criteria for infant regurgitation. Eighty-eight percent of 210 infants who had completed a 24-month follow-up period had improved at the age of 12 months. Only 1 patient later turned out to have gastroesophageal reflux disease. Use of breast milk was associated with a shorter time necessary to reach an Infant Gastroesophageal Reflux Questionnaire score of 0.

Clinical Response to 2 Dosing Regimens of Lansoprazole in Infants With Gastroesophageal Reflux

Proton pump inhibitors such as lansoprazole are used in the treatment of gastroesophageal reflux disease (GERD), but dosing guidelines for infants have not been determined. The objective of this study was to assess the clinical efficacy of 2 dosing regimens of lansoprazole in infants with GERD using the revised infant gastroesophageal reflux questionnaire scores (I-GERQ-R). Thirty consecutive infants (3-7 months) with GERD, whose conditions were diagnosed by I-GERQ-R scores of > or =16, were randomly assigned to receive 1 of 2 lansoprazole dosing regimens: 15 mg given once per day (group A) or approximately 7.5 mg given 2 times per day (group B). Matched infants in a control group were treated with an extensively hydrolyzed formula (group C). Daily I-GERQ-R scores were gathered, and the scores after 1 and 2 weeks of treatment were used for analysis. The mean pretreatment scores were similar in groups A, B, and C (26.6, 26.9, and 25.9, respectively). After treatment there was a similar drop in the mean scores in groups A and B (20.6 and 20.0, respectively), but not in group C (25.8). At the end of the first week of treatment, in group A, 5 of 15 infants (33%) had a significant reduction in their I-GERQ-R scores, whereas in group B, 10 of 15 infants (67%) had a significant reduction in their I-GERQ-R scores (P < 0.05). At the end of the second week of treatment, groups A and B had similar numbers of patients with significant improvement (60% and 67%), which was higher than in group C (3/15, 20%). Overall, there was no difference in the symptom response, as measured by I-GERQ-R scores, between 15 mg of lansoprazole given once per day and 7.5 mg given twice per day in infants with GERD, but the twice-daily regimen produced a faster symptom response. Both regimens were significantly better than treatment of infants with an extensively hydrolyzed formula.

Validation issues in questionnaires for diagnosis and monitoring of gastroesophageal reflux disease in children

Pediatric gastroesophageal reflux disease (GERD) is common in infants and children; diagnosis is often based on symptom presentation. This paper reviews psychometric characteristics and approaches to validation of currently available pediatric GERD questionnaires. Patient-reported outcomes allow disease and treatment to be characterized in meaningful ways to patients and clinicians. Outcome measures must demonstrate reliability and validity for use in practice and in clinical trials. Reliability assesses the consistency of measures, whereas validity examines whether the instrument measures what it is purported to measure. Development of questionnaires for use with children also requires consideration regarding the respondent. Measures of pediatric GERD symptoms include the Infant Gastroesophageal Reflux Questionnaire (GERQ), the GERQ-Revised, and the GERD Symptom Questionnaire. These measures have advantages and disadvantages with regard to feasibility, reliability, and validity. Questionnaires are lacking for children older than 4 years.

The Infant Gastroesophageal Reflux Questionnaire Revised: Development and Validation as an Evaluative Instrument

Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation. A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms. Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001). This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms.

Is Gastroesophageal Reflux Disease Really a Life-Long Disease: Do Babies Who Regurgitate Grow up to Be Adults with GERD Complications?

There are a number of chronic digestive diseases in adults which have symptom and/or disease onset in childhood. Examples of childhood-onset chronic diseases include Helicobacter pylori-associated gastroduodenal disease and gastroesophageal reflux disease (GERD). Unfortunately, there is a paucity of well-designed longitudinal studies that characterize the natural history of each of these conditions and more importantly identify individuals (i.e., children) who are at risk for serious, long-term adult sequelae. Gastroesophageal reflux (GER), the physiological condition, and GERD, the disease, occur frequently during the first 2 yr of life. However, commonly held "dogma" by pediatricians is the belief that the majority of these children "grew out of their GER or GERD symptoms." On the contrary, recent evidence suggests that GERD in some subjects is a chronic, potentially life-long condition that begins in childhood, and in those in whom disease onset is early, there may be a higher risk for long-term severe disease sequelae. The article by Orenstein et al., although small in cohort size (N = 19), is the first systematic, longitudinal prospective study that employs both a validated GERD symptom assessment instrument and a histological characterization of esophageal inflammation via mucosal biopsies of infants during the first year of life. The infants, part of a larger therapeutic trial, were originally referred to the investigators for GERD evaluation, failed a 2-wk lifestyle modification trial, and were randomized to placebo or intervention (acid suppression and prokinetic therapy). This placebo cohort was evaluated in follow-up via assessment of symptoms using a validated Infant-Gastroesophageal-Reflux-Questionnaire (I-GERQ) and esophageal suction biopsy; morphometric characterization of mucosal histology and symptom scores were performed at 2, 4, 6, and 12 months. At the 12-month endpoint, 10 of 19 completed the study without rescue medication and overall symptom scores improved in all 10 completers. However, none of the 10 completers had normalization of biopsy assessments, i.e., basal cell layer <25% and papillary height <53% of epithelial thickness. The authors concluded that although symptoms improved in more than half of infants with reflux esophagitis followed longitudinally, esophageal mucosal histology remained abnormal at the 1-yr evaluation in the absence of pharmacotherapy. The lack of concordant improvement of the esophageal histology should raise concern regarding sub-clinical persistence of ongoing esophageal insult, which might in the long-term, predispose the individual to GERD-related complications, such as strictures, Barrett's esophagus, and/or esophageal adenocarcinoma. In this editorial, the implications of GERD being a life-long disease based on the findings described by Orenstein et al. are discussed. In addition, a description of areas where further research is critically needed is provided namely: (1) population-based, epidemiological studies of GERD with appropriate case and control definitions, (2) characterization of genetically "at-risk" individuals (i.e., with childhood-onset GERD) for severe GERD sequelae (e.g., Barrett's esophagus, esophageal adenocarcinoma), or potentially, (3) longitudinal, family cohort natural history studies with index pediatric GERD cases.

Gastroesophageal Reflux in the Preterm Neonate

After completing this article, readers should be able to: 1. Describe the epidemiology and pathophysiology of gastroesophageal reflux (GER) in preterm neonates. 2. Delineate the associations of GER with apnea, chronic lung disease, behavior, and growth of preterm infants. 3. Review the investigations used to evaluate GER in preterm infants. 4. Describe nonpharmacologic and pharmacologic therapies for GER. Gastroesophageal reflux (GER) is a normal physiologic event occurring across the age spectrum. It may contribute to a variety of disorders, including esophagitis, feeding problems, and airway disease in all age groups. (1) A large number of symptoms and signs have been purported to be caused by GER despite a lack of data showing a clear association between a specific symptom and GER. In preterm infants, empiric therapy often is administered using agents of unproven efficacy and safety to treat symptoms that likely are unrelated to GER. In a survey on management practices for GER in preterm infants, common treatment strategies included positioning (98%) and slopes (96%), histamine 2 (H 2) receptor antagonists (100%), feed thickeners (98%), antacids (96%), prokinetics (79%), proton pump inhibitors (PPIs) (65%), and dopamine receptor antagonists (53%). (2)(3) The safety, efficacy, and appropriate dosing recommendations for most medical therapies remain uncertain in neonates. In this review, we attempt to summarize the current literature regarding physiology, pathophysiology, and diagnostic and management strategies for GER pertinent to the neonate, with an emphasis on the preterm infant. GER describes the retrograde movement of stomach contents (air or feeding, liquid or semisolid, acid or alkaline, enzymes or bile salts) into the esophagus. GER disease (GERD) occurs when GER causes symptoms or signs such as pain, poor weight gain, esophagitis, hematemesis, and airway symptoms, including apnea, aspiration, recurrent pneumonia, chronic lung disease (CLD), or large airway inflammation. However, any of these symptoms or signs …

P0789 CIMETIDINE, CISAPRIDE, BOTH, OR NEITHER FOR INFANTILE ESOPHAGITIS: SYMPTOMATIC RESPONSE TO 4M RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED THERAPY IN 100 BABIES.

Introduction: Gastroesophageal reflux disease (GERD) afflicts 7% of infants. Major symptoms (Sx) are vomiting & crying, conceptualized as reflux of volume & acid, respectively, & thus responsive to prokinetic & anti-acid pharmacotherapy (Rx). This has prompted empiric Rx with both a prokinetic agent & an histamine-2 receptor antagonist, though limited prokinetic options now prompt empiric Rx with acid-suppression alone, without clearly documented efficacy. We compared, in a placebo (P) controlled trial, Sx response of infant esophagitis to 4m Rx with cimetidine 10mg/kg qid (Cm), cisapride 0.2mg/kg qid (Cs), both (B), or neither (N). Methods: Subjects were 100 infants, 1–12m old, referred for GERD Sx July 1, 1994-October 13, 1999, with esophagitis on suction biopsy (Bx), parent consent, and no exclusions. Infants were randomly & blindly assigned to 1 of 4 arms; each took 2 “drugs”: Cm-P, Cs-P, Cm-Cs (i.e., B), or P-P (i.e., N). Sx (Infant Gastroesophageal Reflux Questionnaire, ©1992) & Bx were tested at 0m, 2m, 4m, 6m, & off protocol at 12m. At any visit with both Sx & Bx unimproved, infants were rescued to un-masked Cm-Cs, without un-masking prior Rx. At any visit with both Sx & Bx completely well, infants graduated off Rx. This analysis is Sx at 4m. Statistics chi square, Fischer’s exact, 2-tailed. Results: Enrolled infants were aged 1–11.8m (median 3.5); 63% male; 88% Caucasian. After 4m blinded Rx, Sx became well on assigned Rx in only 15%. Although making up only 24% of enrolled infants, infants on dual placebo comprised 40% of those with resolved Sx (p=0.19 compared to other 3 groups combined). Rx with Both drugs together was less likely to result in withdrawal or rescue than other 3 groups combined (p<.05). Cm alone was more likely to result in withdrawal or rescue than other 3 groups combined (p<.05).Table 1Conclusion: Efficacy of 4m of these pharmacotherapies for Sx of infant esophagitis is uncertain. Cimetidine used alone appears less effective &/or more aversive than all other 3 arms. Use of cimetidine & cisapride together may have protected against withdrawal or rescue, but Sx were completely well at 4m in a greater proportion of dual placebo babies than babies assigned other Rx (NS). Improvement in Sx with dual placebo may be due to the efficacy of “lifestyle modifications” used in all subjects, or to developmental maturation. All treatment trials for infant esophagitis should include placebo controls.

Gastroesophageal reflux.

1. Susan R. Orenstein, MD* 1. 2. *Professor of Pediatrics, Children’s Hospital of Pittsburgh, Division of Pediatric Gastroenterology, Pittsburgh, PA. 3. Dr. Orenstein receives research grant support from the Janssen Research Foundation. Thirty years ago, gastroesophageal reflux disease was virtually unknown; today, it seems necessary to consider it a potential cause of an enormous range of symptoms. Not long ago, reflux was diagnosed simply by ordering an upper gastrointestinal barium study; now the complexity of differentiating between gastroesophageal reflux (GER) episodes and gastroesophageal reflux disease (GERD) mandates an understanding of the strengths and weaknesses of a variety of tests. Several decades ago, few options for therapy of reflux existed, and those that did were not very effective or even frankly detrimental; currently, the range of proven therapeutic options is greater, and the pediatrician must exercise finesse in prescribing these options. It has been useful to consider the symptoms, diagnostic complexity, and therapy of reflux as an“ iceberg” (Figure⇓ ). The largest section at the bottom represents common, easily diagnosed, and easily treated cases; the tip of the iceberg represents those cases that occur less frequently, provide considerable diagnostic and therapeutic challenges, and require subspecialist consultation. Exactly where the demarcation occurs between these sections of the iceberg depends on the individual pediatrician’s expertise and the local availability of subspecialty expertise. Each section that follows will consider both infantile GERD (which is more common) and childhood GERD. Figure 1. The GERD iceberg. Reprinted with permission from Orenstein SR. Di Lorenzo C, Hyman P, Flores A. Pediatric Gastroesophageal Reflux: A Guide for Primary Care Physicians . Slide-lecture program sponsored and distributed by American Pseudo-obstruction and Hirschsprung’s Disease Society, Inc., Medfore MA, 1996. ### INFANTS Regurgitation is the classic symptom of reflux in infancy. However, we now understand that infantile regurgitation is not necessarily GERD (reflux disease) and that GERD may occur without any regurgitation, even in infancy. Other symptoms also should prompt the pediatrician to consider the possibility of GERD affecting an infant (Table 1⇓ ). ### CHILDREN During …

One-year follow-up of symptoms of gastroesophageal reflux during infancy. Pediatric Practice Research Group.

1) Determine what percentage of infants outgrow regurgitation over 1 year. 2) Determine whether they develop feeding or mealtime problems. 3) Determine whether they develop frequent respiratory illnesses, including ear, sinus, and upper respiratory infections, or wheezing episodes. One-year follow-up survey of parents of children identified at 6 to 12 months of age as those who regurgitate (case subjects) and matched control subjects. Sixty-three case subjects and 92 control subjects attending 12 different (urban, suburban, and rural) practices in the Pediatric Practice Research Group in the Chicago area. The Infant Gastroesophageal Reflux Questionnaire-Shortened and Revised Form and the Children's Eating Behavior Inventory (CEBI). At 1-year follow-up, no parents of case or control subject described spitting up as currently a problem. The parent of only one control subject (and no case subject) reported spitting up one or more times a day. Parents of subjects were more likely than those of control subjects to report frequent feeding refusal: odds ratio = 4.2, adjusted by age (95% confidence interval: 1.4-12.0). Case and control subjects had comparable average total CEBI scores (case subjects, = 83 +/- 10 vs control subjects, = 82 +/- 11) and comparable average proportion of items identified as a problem (8% +/- 11% case subjects vs 6% +/- 9% control subjects). Case subjects were more likely to respond positively to two CEBI questions indicating specific feeding problems: 1) "my child takes more than an hour to eat his/her meals" (8% case subjects vs 0% control subjects) and 2) "I get upset when I think about our meals" (14% case subjects vs 4% control subjects). The frequencies of ear, sinus, and upper respiratory infections and of episodes of wheezing were comparable in both groups. 1) Infants with daily or problematic regurgitation at 6 to 12 months of age outgrew this within the following year. 2) Infants with daily or problematic regurgitation were more likely to develop feeding problems. 3) There was no increase in respiratory illnesses in infants with a history of regurgitation.

SYMPTOMS OF GASTROESOPHAGEAL REFLUX DURING INFANCY: A PEDIATRIC PRACTICE-BASED SURVEY. 733

Complaints about symptoms of gastroesophageal reflux (GER) in infants are common in pediatric practice, but few data exist regarding their natural history. This study describes the prevalence of overt GER during the first year of life. METHODS: Office survey of parents of 1294 well infants under one year of age. A shortened and revised form of The Infant Gastroesophageal Reflux Questionnaire (Clin Pediatr 32:472, 1993) was distributed in 19 Chicago area practices. RESULTS: Data are% of infants positive for symptom indicated (all 3 p < 0.001).Table

Reliability and validity of an infant gastroesophageal reflux questionnaire.

To improve history-taking of infants with suspected gastroesophageal reflux, we developed an Infant Gastroesophageal Reflux Questionnaire consisting of 161 items covering demographics, symptoms (regurgitation, weight deficit, respiratory difficulties, fussiness, apnea, and pain or bleeding of esophagitis), and possible causes (feeding volume and frequency, allergy, infection, colic, central nervous system abnormalities, positioning, and smoke exposure). The questionnaire was completed by primary caretakers of 69 infants aged 1 to 58 weeks suspected of having reflux. Median time to complete the questionnaire was 20 minutes. The median internal consistency of 29 pairs of redundant questions was 0.94. Median test-retest consistency of 110 items for nine respondents was 0.88. Median interobserver consistency, evaluated for 129 items in 35 questionnaires also filled out by secondary caretakers, was 0.85. The median accuracy of four externally validated items was 1.00. This questionnaire can aid pediatricians in making decisions regarding diagnoses and treatment in this common but complex disorder.