NCT02620241

Brief Summary

The study evaluates the effect on gastro-oesophageal reflux (GOR) of infants sitting in a stable upright position during 20 min. This is an addendum to the previous study with record number clinical trials.gov NCT02124863

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

November 30, 2015

Last Update Submit

November 6, 2017

Conditions

Gastro-oesophageal Reflux

Keywords

gastro-oesophageal refluxintrapulmonary percussive ventilationpositioning

Outcome Measures

Primary Outcomes (1)

  • number of reflux episodes

    number of reflux episodes is counted over 20 min period of time

    20 minutes

Study Arms (1)

sitting position

OTHER

infants are in a sitting position for 20 minutes

Other: sitting position

Interventions

sitting positionOTHER
sitting position

Eligibility Criteria

Age1 Day - 365 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Each child under the age of one year that was referred for 24h pH-MII monitoring to exclude pathological gastro-oesophageal reflux (GOR)

You may not qualify if:

  • : prematurity (gestational age less than 37 weeks), the use of anti-reflux medication and reflux surgery (Nissen fundoplication)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FVanGinderdeuren

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

BE(1)