Abstract
ObjectiveTo test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants.MethodsInfants (N = 76) between 34 and 60 weeks’ postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones.ResultsOf 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19−49%) vs. 44% (95% CI, 28−62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05).ConclusionsFeeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes.ImpactConservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes.Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes.The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.
Highlights
IntroductionDifferentiating gastroesophageal reflux (physiological, GER) from GER disease (pathological, gastroesophageal reflux disease (GERD)) remains a challenge in ICU infants.[1,2,3,4,5] Troublesome symptoms[6] often trigger a battery of empiric therapies, such as acid suppression, feeding modifications, and positional changes.[7,8,9,10] Prevalence of GERD ranges from 2 to30% across neonatal intensive care unit (NICU)s in the UnitedStates, along with a 13-fold variation in therapies, imposing an additional economic burden of over $70K per admission and 30 hospital days.[9,10,11,12]The infant GER questionnaire-revised (I-GERQ-R) is a survey of parental/provider perception of symptom burden thought to be due to GERD, with a 6-point decrease indicating clinical improvement.[13]
A bundled approach combining targeted acid suppression, feeding modifications and postprandial positions has not been rigorously examined in infants with proven esophageal acid reflux index (ARI) severity
We have undertaken this clinical trial to determine the effective therapeutic strategies on the clinically meaningful primary outcomes in infants presenting with gastroesophageal reflux disease (GERD) symptoms who have qualifying ARI criteria
Summary
Differentiating gastroesophageal reflux (physiological, GER) from GER disease (pathological, GERD) remains a challenge in ICU infants.[1,2,3,4,5] Troublesome symptoms[6] often trigger a battery of empiric therapies, such as acid suppression, feeding modifications, and positional changes.[7,8,9,10] Prevalence of GERD ranges from 2 to30% across neonatal intensive care unit (NICU)s in the UnitedStates, along with a 13-fold variation in therapies, imposing an additional economic burden of over $70K per admission and 30 hospital days.[9,10,11,12]The infant GER questionnaire-revised (I-GERQ-R) is a survey of parental/provider perception of symptom burden thought to be due to GERD, with a 6-point decrease indicating clinical improvement.[13]. Improvement of parental perception of symptoms and total GER events with left lateral position and proton pump inhibitor (PPI),[8] reduction of GER events with infants in prone or left lateral post-prandially,[18] and conservative strategies for 2 weeks showed improvement with I-GERQ-R scores among 1−10 months age.[19] We observed that decreased feeding volume and prolonged feeding duration were associated with reduced GER events.[20] a bundled approach combining targeted acid suppression (limited duration), feeding modifications (volume, position, duration) and postprandial positions has not been rigorously examined in infants with proven esophageal acid reflux index (ARI) severity Based on this rationale, we have undertaken this clinical trial to determine the effective therapeutic strategies on the clinically meaningful primary outcomes in infants presenting with GERD symptoms who have qualifying ARI criteria. Our hypothesis was that the study approach (acid suppression, modified feeding volume, duration, and position) was superior in achieving independent oral feeding or a 6-point reduction in I-GERQ-R vs. the conventional (acid suppression alone) feeding approach
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