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Car Safety Seat and Gastroesophageal Reflux Disease

NCT01266551 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-28

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux Disease and Position

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Study Design

Purpose
TREATMENT

Eligibility

Min Age
2 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01266551 on ClinicalTrials.gov