title: Growth of Infants Fed Formula with Evolving  Nutrition Composition: A Single-Arm Non-Inferiority Study.
abstract: The nutritional composition of human milk evolves over the course of lactation, to match the changing needs of infants. This single-arm, non-inferiority study evaluated growth against the WHO standards in the first year of life, in infants consecutively fed four age-based formulas with compositions tailored to infants' nutritional needs during the 1st, 2nd, 3rd-6th, and 7th-12th months of age. Healthy full-term formula-fed infants (n = 32) were enrolled at ≤14 days of age and exclusively fed study formulas from enrollment, to the age of four months. Powdered study formulas were provided in single-serving capsules that were reconstituted using a dedicated automated preparation system, to ensure precise, hygienic preparation. The primary outcome was the weight-for-age z-score (WAZ) at the age of four months (vs. non-inferiority margin of -0.5 SD). Mean (95% CI) z-scores for the WAZ (0.12 (-0.15, 0.39)), as well as for the length-for-age (0.05 (-0.19, 0.30)), weight-for-length (0.16 (-0.16, 0.48)), BMI-for-age (0.11 (-0.20, 0.43)), and head circumferencefor-age (0.41 (0.16, 0.65)) at the age of four months, were non-inferior. Throughout the study, anthropometric z-scores tracked closely against the WHO standards (within ±1 SD). In sum, a fourstage, age-based infant formula system with nutritional compositions tailored to infants' evolving needs, supports healthy growth consistent with WHO standards, for the first year of life.
authors.affiliation: Department of Gastroenterology and Hepatology, Children's Hospital, CH-6000 Lucerne, Switzerland. johannes.spalinger@luks.ch.
authors.forename: Johannes
authors.initials: J
authors.lastname: Spalinger
authors.affiliation: Department of Pediatric Gastroenterology, University Children's Hospital, CH-1011 Lausanne, Switzerland. Andreas.Nydegger@chuv.ch.
authors.forename: Andreas
authors.initials: A
authors.lastname: Nydegger
authors.affiliation: Department of Pediatrics, University Hospital of Geneva, CH-1205 Geneva, Switzerland. Dominique.Belli@hcuge.ch.
authors.forename: Dominique
authors.initials: D
authors.lastname: Belli
authors.affiliation: Department of Pediatrics, University Children's Hospital Basel (UKBB), CH-4031 Basel, Switzerland. raoul.furlano@ukbb.ch.
authors.forename: Raoul I
authors.initials: RI
authors.lastname: Furlano
authors.affiliation: Nestlé Nutrition Research, King of Prussia, PA 19406, USA. jian.yan@rd.nestle.com.
authors.forename: Jian
authors.initials: J
authors.lastname: Yan
authors.affiliation: Nestlé Research Center, CH-1000 Lausanne, Switzerland. jerome.tanguy@rdls.nestle.com.
authors.forename: Jerome
authors.initials: J
authors.lastname: Tanguy
authors.affiliation: Nestlé Nutrition Research, CH-1800 Vevey, Switzerland. sophie.pecquet@nestle.com.
authors.forename: Sophie
authors.initials: S
authors.lastname: Pecquet
authors.affiliation: Nestlé Product Technology Center, CH-1800 Vevey, Switzerland. frederic.destaillats@nestle.com.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Destaillats
authors.affiliation: Nestlé Nutrition Medical, Scientific and Regulatory affairs Unit, CH-1800 Vevey, Switzerland. delphine.egli@nestle.com.
authors.forename: Delphine
authors.initials: D
authors.lastname: Egli
authors.affiliation: Nestlé Health Science, CH-1800 Vevey, Switzerland.
authors.forename: Philippe
authors.initials: P
authors.lastname: Steenhout
mesh_terms: D001827:Body Height / Q000208:ethnology; D015992:Body Mass Index; D002657:Child Development; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D057238:Growth Charts; D006257:Head; D006801:Humans; D041943:Infant Formula / Q000009:adverse effects*; D007231:Infant, Newborn; D059012:Lost to Follow-Up; D008297:Male; D009753:Nutritive Value; D050177:Overweight / Q000453:epidemiology / Q000208:ethnology / Q000209:etiology*; D010352:Patient Dropouts / Q000208:ethnology; D063766:Pediatric Obesity / Q000453:epidemiology / Q000208:ethnology / Q000209:etiology*; D012307:Risk Factors; D013557:Switzerland / Q000453:epidemiology; D014504:Urban Health / Q000208:ethnology; D015430:Weight Gain / Q000208:ethnology; D014944:World Health Organization
keywords: human milk;  WHO growth standard;  evolving nutritional composition;  infant formula;  personalized nutrition;  protein;  staged‐formula  delivery system