TerminatedNot Applicable

Car Safety Seat and Gastroesophageal Reflux Disease

Stopped: Intended number of patients reached

BelgiumStarted 2008-10

Plain-language 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.

Who can participate

Age range2 Weeks – 6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Trial details

NCT IDNCT01266551

SponsorUniversity Hospital, Antwerp

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-08

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease and Position trials