Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
INTERVENTIONAL
2008-10-31
2010-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Study Groups
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lifestyle counseling
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.
car safety seat
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.
Interventions
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car safety seat
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.
Eligibility Criteria
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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.
2 Weeks
6 Months
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Locations
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Antwerp University Hospital
Antwerp, , Belgium
Countries
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Other Identifiers
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3204
Identifier Type: -
Identifier Source: org_study_id
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