Inclined Positioning and Infant Gastroesophageal Reflux
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      The purpose of this voluntary research study is to evaluate the extent to which infants with
      Gastroesophageal Reflux (GER) exhibit oxygen desaturation (low oxygen levels in their blood)
      and bradycardia (slow heart rate) in supine (lying flat on back) and inclined positions.
    

Detailed description: 
      Mothers will bring their infants to the Clinical Research Center where they will be escorted
      to a private room. Participants will proceed to feed their infant a typical liquid meal (i.e.
      breastmilk or formula). Within 15 minutes of completion of the feed, infants will be placed
      in the prototype infant reclining device at either 0, 10, 18, or 28 degrees of incline.
      Infants will spend 15 minutes at each level of incline in a randomly assigned order. During
      this time period that each infant is under observation the infant may be
      entertained/distracted/comforted with white noise, music or other forms of distraction as
      determined by the mother or study team. Mothers may touch/caress their infant or use a
      pacifier to soothe infant as needed so long as each 15 minute segment is completed. Following
      each 15 minute segment, a "washout" period will be used such that the next 15 minute segment
      will not begin for a minimum of 1 minute to a maximum of 5 minutes in duration before the
      next incline position is begun. This allows for a clean start and stop period for each 15
      minute segment that is not impacted by either the prior position or the change to the new
      position. This also allows mothers or study staff to pick up and comfort the infant.

      During each of the four 15 minute segments, infants will be monitored using the Masimo RAD-97
      pulse oximeter with data continuously collected regarding oxygen saturation and heart rate in
      2-second intervals. The oxygen saturation probe will preferably be attached to a big toe, but
      can be placed in alternative spots consistent with usual clinical care such that a consistent
      reading of heart rate and oxygen saturation are recorded. A study coordinator will complete a
      data collection form for each segment characterizing whether GER occurred (spit-up into mouth
      or outside of mouth), the number of GER episodes as well as a subjective assessment of degree
      crying/fussing, hiccups, back arching, and breathing difficulty. The coordinator will also
      have a timer to measure the duration of crying in each position. Infants will be video
      recorded as a backup method for symptom assessment and for qualitative assessments by the
      study sponsor.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be identified through providers in the Divisions of Academic General
        Pediatrics, Hospital Pediatrics, and Pediatric Gastroenterology. The Department of Family
        and Community Medicine may also refer participants to the study.