Gastroesophageal RefluxNCT02167984
Esophageal Bolus Transit in Newborns With Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux, run by University of Turin, Italy at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Gastroesophageal Reflux
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: newborns consecutively admitted to the Torino University NICU who underwent 24-hour MII/pH for suspected GERD
Who may be able to join
- Clinical presentations included regurgitation/vomiting, apnea and desaturations, coughing, feed refusal, irritability, crying, back arching, failure to thrive.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esophageal Bolus Transit in GERD Newborns: a Multichannel Intraluminal Impedance Study
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.
- Conditions
- Gastroesophageal Reflux
- Keywords
- esophageal swallow, gastroesophageal reflux, esophageal impedance, newborn, preterm
- Medical subject headings
- Gastroesophageal Reflux, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| at term newborns | Infant with GE >=37w | |
| preterm newborns | Infant with GE <37w |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: calculated throughout 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Cresi, MD, PhD, University of Turin, Italy
- Investigators
- Francesco Cresi, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167984
- Sponsor's protocol ID
- swallow-01
- Status last verified
- May 2018
- First submitted
- 17 Jun 2014
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esophageal Bolus Transit in GERD Newborns: a Multichannel Intraluminal Impedance Study
- ClinicalTrials.gov ID
- NCT02167984
- Acronym / sponsor ID
- swallow-01
- Conditions
- Gastroesophageal Reflux
- Keywords
- esophageal swallow, gastroesophageal reflux, esophageal impedance, newborn, preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| at term newborns | – | –Infant with GE >=37w |
| preterm newborns | – | –Infant with GE <37w |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborns consecutively admitted to the Torino University NICU who underwent 24-hour MII/pH for suspected GERD
Key inclusion criteria (1 listed)
- Clinical presentations included regurgitation/vomiting, apnea and desaturations, coughing, feed refusal, irritability, crying, back arching, failure to thrive.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BPT, BHAT, BHATc
Time frame: calculated throughout 24 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Cresi, MD principal investigator
University of Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPT, BHAT, BHATc (time frame: calculated throughout 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.