Esophageal Bolus Transit in Newborns With Gastroesophageal Reflux Disease

NCT02167984 | Completed

• 1 other identifier: swallow-01
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal dysmotility due to immaturity could promote impaired bolus transit during esophageal swallow events,thus influencing gastroesophageal reflux (GER) clearance. Aim of this study was to describe esophageal bolus transit characteristics during swallow and to evaluate the relationship between esophageal swallow (ES) and GER in newborns with gastroesophageal reflux disease symptoms using multichannel intraluminal impedance. The simultaneous analysis of swallow and GER events in newborns undergone MII/pH monitoring could provide useful information to better understand the physiopathology of gastroesophageal reflux disease (GERD) and could help clinicians to identify newborns with prolonged esophageal clearance time, making the recommendations for further tests and the therapeutic approach more accurate

Conditions

Gastroesophageal Reflux

Keywords

esophageal swallow; gastroesophageal reflux; esophageal impedance; newborn; preterm

Outcome Measures

Primary Outcomes (1)

• BPT, BHAT, BHATc

  bolus presence time (BPT): time between bolus entrance and exit recorded in the distal channel, measured in seconds; bolus head advancing time (BHAT): time between the bolus entrance recorded in the proximal channel and the bolus entrance recorded in the distal channel, measured in seconds; bolus head advancing time corrected (BHATc): BHAT corrected for esophageal length, expressed in seconds/cm. BHATc was calculated using the formula BHATc = BHAT / esophageal length

  calculated throughout 24 hours

Study Arms (2)

at term newborns

Infant with GE \>=37w

preterm newborns

Infant with GE \<37w

Eligibility Criteria

• Age: 1 Day - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

newborns consecutively admitted to the Torino University NICU who underwent 24-hour MII/pH for suspected GERD

You may qualify if:

• Clinical presentations included regurgitation/vomiting, apnea and desaturations, coughing, feed refusal, irritability, crying, back arching, failure to thrive.

You may not qualify if:

• Presence of congenital abnormalities, perinatal asphyxiation or neurological pathologies Taking drug known to influence esophageal motor function. Anti-reflux treatment was ceased 1 week before MII/pH.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Ospedale OIRM - S.Anna di Torino

Torino, (TO), 10126, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Premature Birth

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Francesco Cresi, MD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: January 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)