Lack of efficacy of a starch-thickened preterm formula on gastro-oesophageal reflux in preterm infants: a pilot study

J Matern Fetal Neonatal Med. 2012 Dec;25(12):2735-8. doi: 10.3109/14767058.2012.704440. Epub 2012 Jul 13.

Abstract

Background: Gastro-oesophageal reflux (GOR) is common in preterm infants; conservative interventions (i.e. dietary changes) should represent the first-line approach.

Aim: To evaluate by combined pH and impedance monitoring (pH-MII) the effect of a new preterm formula thickened with amylopectin (TPF) on GOR features in symptomatic preterm infants.

Methods: Twenty-eight symptomatic preterm newborns underwent a 24-hour pH-MII; each baby received eight meals (four of TPF and four of a preterm formula [PF]). GOR indexes (number, acidity, duration and height of GORs) after TPF and PF meals were compared by Wilcoxon Signed Ranks Test. Viscosity of PF and TPF was measured.

Results: TPF significantly decreased the number of acid GORs detected by pH-monitoring (TPF vs. PF: median 20 vs. 24.5, p = 0.009), while it had no influence on Reflux Index (RIpH), nor on acid and non-acid GOR indexes detected by MII, GOR physical features, and GOR height. TPF's viscosity was extremely higher than PF's, and further increased at pH 3 after the addition of pepsin.

Conclusions: The new formula was found to reduce the number of acid GORs detected by pH-monitoring; it did not reduce neither total oesophageal acid exposure nor non-acid GORs. At present its extended clinical use cannot be recommended.

Publication types

  • Clinical Trial

MeSH terms

  • Dietary Supplements
  • Electric Impedance
  • Esophagus / chemistry
  • Esophagus / metabolism
  • Esophagus / physiopathology
  • Female
  • Food, Fortified
  • Gastroesophageal Reflux / congenital
  • Gastroesophageal Reflux / diagnosis
  • Gastroesophageal Reflux / diet therapy*
  • Gastroesophageal Reflux / metabolism
  • Gestational Age
  • Humans
  • Hydrogen-Ion Concentration
  • Infant Formula / administration & dosage*
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / diagnosis
  • Infant, Premature, Diseases / diet therapy*
  • Male
  • Pilot Projects
  • Starch / administration & dosage*
  • Treatment Outcome

Substances

  • Starch