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Objective: Proton-pump inhibitors (PPIs) reduce acid gastroesophageal reflux (GER) and esophageal acid exposure in infants; however, they do not reduce total GER or symptoms attributed to GER. Reflux is reduced in the left lateral position (LLP). We hypothesize that the effect of LLP in combination with acid suppression is most effective in reducing GER symptoms in infants., Methods: In this prospective sham-controlled trial, infants (0-6 months) with symptoms suggestive of gastroesophageal reflux disease were studied using 8-hour pH-impedance, cardiorespiratory and video monitoring, direct nurse observation, and a validated questionnaire. Infants demonstrating a positive GER symptom association were randomized to 1 of 4 groups; PPI + LLP, PPI + head of cot elevation (HE), antacid (AA) + LLP, or AA + HE. HE and AA were considered "sham" therapies. After 2 weeks the 8-hour studies were repeated on-therapy., Results: Fifty-one patients were included (aged 13.6 [2-26] weeks). PPI + LLP was most effective in reducing GER episodes (69 [13] to 46 [10], P < 0.001) and esophageal acid exposure (median [interquartile range] 8.9% [3.1%-18.1%] to 1.1% [0%-4.4%], P = 0.02). No treatment group showed improvement in crying/irritability, although vomiting was reduced in AA + LLP (from 7 [2] to 2 [0] episodes P = 0.042). LLP compared with HE produced greater reduction in total GER (-21 [4] vs -10 [4], P = 0.056), regardless of acid-suppressive therapy. Acid exposure was reduced on PPI compared with AA (-6.8 [2.1] vs -0.9 [1.4]%, pH < 4, P = 0.043) regardless of positional intervention. A post-hoc analysis using automated analysis software revealed a significant reduction in crying symptoms in the PPI + LLP group (99 [65-103] to 62 [32-96] episodes, P = 0.018)., Conclusions: "Symptomatic gastroesophageal reflux disease" implies disease causation for distressing infant symptoms. In infants with symptoms attributed to GER, LLP produced a significant reduction in total GER, but did not result in a significant improvement in symptoms other than vomiting; however, automated analysis appeared to identify infants with GER-associated crying symptoms who responded to positioning therapy. This is an important new insight for future research.

Objective: To investigate the threshold amount of constantly infused feed needed to trigger lower esophageal sphincter relaxation (TLESR) in the right lateral position (RLP) and left lateral position (LLP)., Study Design: Eight healthy infants (3 male; gestational age: 32.9 +/- 2.4 weeks; corrected age: 36.1 +/- 1.3 weeks) were studied using an esophageal impedance-manometry catheter incorporating an intragastric infusion port. After tube placement, infants were randomly positioned in RLP or LLP. They were then tube-fed their normal feed (62.5 [40 to 75] mL) at an infusion rate of 160 mL/h. Recordings were made during the feed and 15 minutes thereafter. The study was repeated with the infant in the opposite position., Results: More TLESRs were triggered in the RLP compared with LLP (4.0 [3.0 to 6.0] vs 2.5 [1.0 to 3.0], P = .027). First TLESR occurred at a significantly lower infused volume in RLP compared with LLP (10.6 +/- 9.4 vs 21.0 +/- 4.9 mL, P = .006). The percentage of feed infused at time of first TLESR was significantly lower in RLP compared with LLP (17.6% +/- 15.5% vs 35.4% +/- 8.02%, P = .005)., Conclusions: In the RLP, TLESRs and gastroesophageal reflux are triggered at volumes unlikely to induce gastric distension.

Objective: To characterize the pharmacodynamics and systemic exposure of esomeprazole in 26 preterm infants and term neonates with symptoms of gastroesophageal reflux and pathologic acid exposure., Study Design: Enrolled patients received oral esomeprazole 0.5 mg/kg once daily for 7 days. Twenty-four-hour esophagogastric pH-impedance monitoring was performed at baseline and on day 7. Pharmacokinetic analysis was performed on day 7. Symptoms occurring during the baseline and day 7 studies were recorded on a symptom chart., Results: There were no significant differences from baseline to day 7 of therapy in the frequency of bolus reflux, consistency of bolus reflux (liquid, mixed, or gas), extent of bolus reflux, or bolus clearance time. Acid bolus reflux episodes were reduced on therapy (median 30 vs 8, P < .001), as was the reflux index (mean % time esophageal pH < 4, 15.7% vs 7.1%, P < .001). The estimated geometric mean of area under the plasma concentration time curve during the dosing interval and observed maximum plasma concentration was 2.5 micromol x h/L and 0.74 micromol/L, respectively. The number of gastroesophageal reflux symptoms recorded over 24 hours was lower on therapy (median 22 vs 12, P < .05)., Conclusions: In preterm infants and term neonates esomeprazole produces no change in bolus reflux characteristics despite significant acid suppression.

Objective: To identify a body-positioning regimen that promotes gastric emptying (GE) and reduces gastroesophageal reflux (GER) by changing body position 1 hour after feeding., Study Design: Ten healthy preterm infants (7 male; mean postmenstrual age, 36 weeks [range, 33 to 38 weeks]) were monitored with combined esophageal impedance-manometry. Infants were positioned in the left lateral position (LLP) or right lateral position (RLP) and then gavage-fed. After 1 hour, the position was changed to the opposite side. Subsequently, all infants were restudied with the order of positioning reversed., Results: There was more liquid GER in the RLP than in the LLP (median, 9.5 [range, 6.0 to 22.0] vs 2.0 [range, 0.0 to 5.0] episodes/hour; P = .002). In the RLP-first protocol, the number of liquid GER episodes per hour decreased significantly after position change (first postprandial hour [RLP], 5.5 [2.0 to 13.0] vs second postprandial hour [LLP], 0.0 [0.0 to 1.0]; P = .002). GE was faster in the RLP-first protocol than in the LLP-first protocol (37.0 +/- 21.1 vs 61.2 +/- 24.8 minutes; P = .006)., Conclusions: A strategy of right lateral positioning for the first postprandial hour with a position change to the left thereafter promotes GE and reduces liquid GER in the late postprandial period and may prove to be a simple therapeutic approach for infants with GER disease.

Background: Transient lower oesophageal sphincter relaxation (TLOSR) is the predominant mechanism of gastro-oesophageal reflux (GOR) in healthy infants but the mechanisms of GOR in infants with GOR disease (GORD) are poorly understood., Aims: To measure the occurrence of TLOSR, GOR, and gastric emptying (GE) rate in preterm and term infants with GORD., Patients: Thirty six infants were studied and grouped as normals or GORD based on a routine clinical assessment and confirmation of an assessment of GORD by reflux symptom charts and oesophageal pH monitoring., Methods: A micromanometric assembly incorporating a micro pH electrode recorded oesophageal motility and pH. GE rate was determined using the (13)C-octanoic acid breath test., Results: TLOSR was the predominant mechanism of GOR, triggering 50-100% of GOR episodes (median 91.5%). Abdominothoracic straining significantly increased the occurrence of GOR in association with TLOSR. In infants with GORD, the number of TLOSRs overall was similar to normals but the proportion of TLOSRs accompanied by acid GOR was significantly higher than in normals (16.5% v 5.7%, respectively; p<0.001). Infants with GORD had a similar GE rate to normals., Conclusions: In infant GORD, acid reflux associated TLOSRs are abnormally common and likely to be a major contributing factor to the pathophysiology of GORD. Infants with GORD do not have delayed GE.

Background: The belief that behavioral observations assist in the clinical diagnosis of gastroesophageal reflux (GER) disease in premature neonates has not been formally tested. The purpose of this study was to determine whether esophageal acidification was associated with a recognizable pattern of behavioral changes in these infants., Methods: The behavior of 14 healthy premature infants was recorded by a video camera while esophageal pH was simultaneously monitored. For each of 20 acid GER episodes recorded, a 10-minute video epoch, encompassing the onset of acid GER and lasting at least 4 minutes after the onset of GER, was examined. Two independent observers each scored reflux-associated epochs of "general" infant behavior and behavior previously shown to be indicative of reflux in normal term infants., Results: The occurrence of esophageal acidification due to reflux did not significantly alter scores for general behavior. Infants frequently demonstrated reflux-specific behavior, including discomfort, head retraction, and mouthing; however, none of these behavioral patterns was temporally associated with the occurrence of acid GER., Conclusions: These data indicate that reflux-specific behavioral criteria, established in older term infants, may be inappropriate as diagnostic criteria for GER in premature neonates and may lead to the unnecessary use of antireflux therapy.

Background/purpose: The aim of this study was to characterize the motor events responsible for gastroesophageal reflux (GER) and esophageal acid clearance in a cohort of preterm infants with chronic lung disease (CLD)., Methods: Esophageal motility was recorded for 2 to 3 hours postprandially in 14 preterm infants with mild-moderate or moderate-severe CLD at 33 to 39 weeks postmenstrual age using a sleeve-side hole micromanometric assembly into which a pH probe had been installed., Results: Twenty-six acid GER episodes were recorded by pH probe. Of these, 22 (85%) were associated with transient lower esophageal sphincter (LES) relaxation. Transient LES relaxations were significantly longer in duration than single swallows (13.7 seconds v 4.6 seconds, P < .001) and had lower nadir pressures (1.1 mm Hg v 2.5 mm Hg, P < .001). During periods of esophageal acidification (pH below 4), peristaltic esophageal body pressure wave sequences cleared acid refluxate more effectively than nonperistaltic pressure wave sequences., Conclusions: In preterm infants with CLD, transient LES relaxations are the predominant mechanism underlying GER, and esophageal clearance mechanisms are fully functional, which is similar to that seen in healthy preterm infants.

Objectives: The aim of this study was to characterize the motor events responsible for gastroesophageal reflux (GER) and esophageal acid clearance in a cohort of healthy preterm infants., Study Design: Esophageal motility was recorded for 2 to 3 hours after a feeding in 24 preterm infants, 31 to 38 weeks' postmenstrual age, by using a sleeveside hole micromanometric assembly incorporating a pH probe., Results: Sixty acid GER episodes were recorded by pH probe, and 133 non-acid GER episodes were recorded manometrically by the presence of esophageal common cavities. Of the 193 GER episodes, 159 (82%) were associated with transient lower esophageal sphincter relaxation (TLESR). TLESRs were significantly longer in duration than single swallows (15.1 seconds vs 5.6 seconds, P < .001) and had lower nadir pressures (0.8 mm Hg vs 2.3 mm Hg, P < .001). A total of 3216 esophageal body pressure waves were analyzed; 70% of swallow-induced pressure waves were peristaltic in sequence compared with 5% of swallow-unrelated pressure waves. During periods of esophageal acidification (pH below 4), peristaltic esophageal body pressure wave sequences cleared acid refluxate more effectively than nonperistaltic pressure wave sequences., Conclusions: In healthy preterm infants, TLESRs are the predominant mechanism underlying GER, and esophageal clearance mechanisms are well developed by at least 31 weeks' postmenstrual age.

Objective: To assess the effect of cisapride on gastric emptying and gastro-oesophageal reflux (GOR) symptoms in preterm infants with feed intolerance.Methods: Sixteen preterm infants (gestational age 24-35 weeks) with feed intolerance were enrolled in the study. Infants were randomized to receive 7 days of cisapride 0.2 mg/kg four times a day, immediately followed by 7 days of placebo or vice versa. Gastric emptying was measured using the [13C]-octanoic acid breath test prior to study entry and repeated on day 5, 6 or 7 after randomization and 5, 6 or 7 days after crossover. The symptoms of GOR were monitored during the study period using a standardized reflux chart. Weight was recorded daily.Results: There was no change in gastric emptying in infants prescribed cisapride (gastric half-emptying time (t1/2) 31.9 +/- 4.7 vs 34.2 +/- 3.9 min for placebo vs cisapride, respectively; P = 0.65). Infants on cisapride had slower growth and there was no change in reflux symptoms.Conclusions: The use of cisapride in preterm infants with feed intolerance cannot be recommended. [ABSTRACT FROM AUTHOR]