Lack of efficacy of a starch-thickened preterm formula on gastro-oesophageal reflux in preterm infants: a pilot study.
BACKGROUND
Gastro-oesophageal reflux (GOR) is common in preterm infants; conservative interventions (i.e. dietary changes) should represent the first-line approach.


OBJECTIVE
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.
Neonatology and Neonatal Intensive Care Unit, S. Orsola-Malpighi Hospital, University of Bologna ,  Bologna ,  Italy.
Luigi
L
Corvaglia
Arianna
A
Aceti
Elisa
E
Mariani
Elena
E
Legnani
Marianna
M
Ferlini
Genny
G
Raffaeli
Giacomo
G
Faldella
D019587:Dietary Supplements; D017097:Electric Impedance; D004947:Esophagus / Q000737:chemistry / Q000378:metabolism / Q000503:physiopathology; D005260:Female; D005527:Food, Fortified; D005764:Gastroesophageal Reflux / Q000151:congenital / Q000175:diagnosis / Q000178:diet therapy* / Q000378:metabolism; D005865:Gestational Age; D006801:Humans; D006863:Hydrogen-Ion Concentration; D041943:Infant Formula / Q000008:administration & dosage*; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000175:diagnosis / Q000178:diet therapy*; D008297:Male; D010865:Pilot Projects; D013213:Starch / Q000008:administration & dosage*; D016896:Treatment Outcome
D013213:Starch