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CompletedNCT02167984Updated May 15, 2018

Esophageal Bolus Transit in Newborns With Gastroesophageal Reflux Disease

An observational study in Gastroesophageal Reflux, sponsored by University of Turin, Italy. Completed at 1 site in Italy. Open to participants aged 1 Day to 90 Days. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by University of Turin, Italy · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
61
Ages
1 Day to 90 Days
Sex
All
01

Study 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

Read the detailed description

The aim of this study was to evaluate esophageal swallow (ES) frequency and characteristics in term and preterm newborns with GERD symptoms using MII and to investigate the possible relationship between ES and GER events.

MATERIAL AND METHODS

The MII tracings from the beginning of the second feeding up to 3 hours after the end of the meal were visually analyzed by two independent investigators using Bioview Analysis software (Sandhill Scientific Inc., Highlands Ranch, Colorado, USA) to identify and characterize ES and GER events.

ES events An ES event was identified as a rapid increase in impedance which precedes a drop in impedance to 50% of baseline beginning in the proximal channel and preceding in an anterograde direction to the most distal channel, followed by the recovery of baseline values at each channel.13 The ES events detected by MII/pH were grouped into mealtime events (the first nine consecutive ES events with no artifacts after the beginning of the meal) and postprandial period events (all the ES events detected in the 3 hours following the end of the meal).

ES event frequency (ES events/hour) was measured, along with the following ES event characteristics:

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 where esophageal length is the distance between proximal and distal impedance channels, measured in cm.

GER events

A GER event was defined as a retrograde drop in impedance to 50% of baseline, beginning in the most distal channel and proceding to one or more proximal channels, of at least 5 seconds, followed by an impedance recovery of baseline values.GER event frequency was measured (GER events/hour), along with the following event characteristics:

bolus reflux extent (BRE):the proximal extent reached by the refluxate, shown by the number of channels sequentially involved in the impedance drop,measured in number of channels; bolus clearance time (BCT):time from onset, at the 50% drop in impedance signal from baseline, to the end of the event, at the 50% recovery point from nadir to baseline, recorded in the distal impedance channel, measured in second.

Statistical Analysis The distribution of all the continuous variables was assessed by the Shapiro-Wilk test. The differences in MII variables between different groups of infants were evaluated with the Mann-Whitney test; the Wilcoxon test was used to compare paired data. Group correlations were analyzedwith the Spearman correlation test. Statistical significance was set at p\<0.05.

02

Conditions studied

  • Gastroesophageal Reflux

Keywords

  • esophageal swallow
  • gastroesophageal reflux
  • esophageal impedance
  • newborn
  • preterm
03

In context

Gastroesophageal Reflux

1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.

This study's enrollment of 61 is below the median of 175 across 304 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

University of Turin, Italy is the lead sponsor of 213 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 90 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
61 participants (actual)
Patient registry
No

Groups and cohorts

  • at term newborns

    Infant with GE \>=37w

  • preterm newborns

    Infant with GE \<37w

06

What researchers measure

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

    Time frame: calculated throughout 24 hours

07

Study locations

1 site
  • Ospedale OIRM - S.Anna di Torino
    Torino, (TO) 10126, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02167984
Responsible party
Francesco Cresi, MD, PhD (MD, University of Turin, Italy) — Principal investigator
First posted
Jun 19, 2014
Start date
Jan 2009
Primary completion
Mar 2013
Completion
Mar 2013
Last update
May 15, 2018

Study contacts

Francesco Cresi, MD
principal investigator · University of Turin, Italy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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