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Efficacy of a pre-thickened infant formula: a multicenter, double-blind, randomized, placebo-controlled parallel

Jon A Vanderhoof1, J Roberto Moran, Cheryl L Harris

  • 1Joint Section of Pediatric Gastroenterology and Nutrition, University of Nebraska Medical Center and Creighton University, Omaha, Nebraska, USA.

Clinical Pediatrics
|August 19, 2003
PubMed

Insights

A pre-thickened infant formula, Enfamil AR, effectively reduced regurgitation and choking symptoms within one week. It also improved sleep for the most symptomatic infants after five weeks without causing constipation.

Area of Science:

  • Pediatrics
  • Gastroenterology
  • Clinical Nutrition

Background:

  • Gastroesophageal reflux is common in infants.
  • Regurgitation can lead to feeding difficulties and discomfort.
  • Standard infant formulas may not adequately address reflux symptoms.

Purpose of the Study:

  • To evaluate the efficacy of a pre-thickened infant formula (Enfamil AR) in managing regurgitant gastroesophageal reflux.
  • To assess the impact of Enfamil AR on regurgitation, choking, and sleep disturbances in infants.

Main Methods:

  • A 5-week, multicenter, double-blind, randomized, placebo-controlled trial.
  • 104 infants with regurgitant gastroesophageal reflux were enrolled.
  • Infants were assigned to either Enfamil AR or a placebo formula.

Main Results:

  • Enfamil AR significantly reduced regurgitation and choking symptoms within the first week.
  • A notable decrease in the percentage of feedings with regurgitation (p = 0.045) and choking (p = 0.004) was observed.
  • The most symptomatic infants showed significant improvement in sleep by study end (p = 0.030) with Enfamil AR, without increased constipation.

Conclusions:

  • Enfamil AR is effective in reducing regurgitation and associated symptoms in infants.
  • The pre-thickened formula improves infant sleep without adverse effects like constipation.
  • Enfamil AR offers a viable option for managing infant gastroesophageal reflux.

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