Car Safety Seat and Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease and Position
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
car safety seat
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease and Position focused on measuring Antireflux procedure, Gastroesophageal reflux, Infant sleep position, pH monitoring
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria were: healthy term-born infants between two weeks and six months old suspected to have GERD, in general good health. The infants did not need to meet the criteria for GERD to be eligible.
Exclusion Criteria:
- Exclusion criteria were infants with psychomotor retardation, acute illness or contra-indication for pH monitoring.
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
lifestyle counseling
Arm Description
The positions in the car safety seat and in supine 15 degrees anti-Trendelenburg are compared on the basis of a 20 hour pH monitoring. In one group the infants were first continuously positioned at 45 degrees elevation in a car safety seat (car safety seat type Maxi cosi Citi for infants from 0-13kg). During the next period the infants were kept in a supine 15 degrees anti-Trendelenburg position (hospital infant bed), and vice versa for the other group.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01266551
First Posted
December 21, 2010
Last Updated
January 25, 2021
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT01266551
Brief Title
Car Safety Seat and Gastroesophageal Reflux Disease
Official Title
The Car Safety Seat; Cause of Increased Gastroesophageal Reflux Disease in Infants?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Intended number of patients reached
Study Start Date
October 2008 (Actual)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
What's known? Prone position is no longer a treatment option for GERD because of the association with SIDS. Originally, positioning in an infant seat was recommended for infants with GERD. However, Orenstein proved this position has a detrimental effect on GER, compared to prone positioning.
What's new? Positioning in an infant seat caused no increase in GER, compared with the supine 15 degrees anti-Trendelenburg position. Except for the number of long reflux episodes, which was significantly higher in the car safety seat. Larger trials are needed for decisive conclusions.
Detailed Description
OBJECTIVE - Over the past few decades, an increase in gastroesophageal reflux disease (GERD) has been seen in infants. This increase may be due to a continuous growth in the use of car safety seats. The objective of this study was to evaluate this hypothesis by comparing positioning in a car safety seat with the supine 15 degrees anti-Trendelenburg position.
PATIENTS AND METHODS - From October 2008 till August 2010 a crossover, randomized, controlled trial was performed on 31 infants, aged two weeks to six months old, who were suspected to have GERD. Twenty hour continuous esophageal pH monitoring was used to compare both positions.
RESULTS - The results of this trial demonstrated no differences between positioning in a car safety seat and in supine 15 degrees anti-Trendelenburg position for the reflux index, the duration of the longest reflux episode and number of reflux episodes (PRI = NS; PLRE = NS respectively PNRE = NS). Only the difference between the number of reflux episodes lasting longer than five minutes was significant (PNRE5 = 0,05).
CONCLUSIONS - The results of this study suggest that an increase in GERD is not caused by a growing use of car safety seats in infants. As the sample size was limited, larger trials are needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease and Position
Keywords
Antireflux procedure, Gastroesophageal reflux, Infant sleep position, pH monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
lifestyle counseling
Arm Type
No Intervention
Arm Description
The positions in the car safety seat and in supine 15 degrees anti-Trendelenburg are compared on the basis of a 20 hour pH monitoring. In one group the infants were first continuously positioned at 45 degrees elevation in a car safety seat (car safety seat type Maxi cosi Citi for infants from 0-13kg). During the next period the infants were kept in a supine 15 degrees anti-Trendelenburg position (hospital infant bed), and vice versa for the other group.
Intervention Type
Device
Intervention Name(s)
car safety seat
Intervention Description
The positions in the car safety seat and in supine 15 degrees anti-Trendelenburg are compared on the basis of a 20 hour pH monitoring.In one group the infants were first continuously positioned at 45 degrees elevation in a car safety seat (car safety seat type Maxi cosi Citi for infants from 0-13kg). During the next period the infants were kept in a supine 15 degrees anti-Trendelenburg position (hospital infant bed), and vice versa for the other group.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria were: healthy term-born infants between two weeks and six months old suspected to have GERD, in general good health. The infants did not need to meet the criteria for GERD to be eligible.
Exclusion Criteria:
Exclusion criteria were infants with psychomotor retardation, acute illness or contra-indication for pH monitoring.
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Car Safety Seat and Gastroesophageal Reflux Disease
We'll reach out to this number within 24 hrs