title: Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study.
abstract: Recent studies have suggested that the gut microflora has metabolic effects. We aimed to evaluate postnatal growth in preterm infants who received different probiotic supplements, and to assess the safety of probiotic administration.
  
  
  
  This prospective, randomized, double-blind, controlled trial was performed at three tertiary care neonatal units. Preterm infants were randomly assigned to receive daily supplementation over 4-6 weeks with placebo (group C) or probiotics (group P). Group P comprised three subgroups: P1 received Bifidobacterium lactis, P2 received Bifidobacterium longum, and P3 received B. lactis and B. longum. We assessed postnatal growth during the supplementation period and up to a corrected gestational age (GA) of 41 weeks when body composition was assessed using whole-body dual-energy X-ray absorptiometry. Aerobic and anaerobic blood cultures were performed on suspicion of late-onset sepsis.
  
  
  
  The study comprised 199 preterm infants with a mean GA of 29.1 ± 1.4 weeks and a mean birth weight of 1173 ± 210 g, who received a placebo (group C, n = 52) or probiotics (group P, n = 147) from the first week of life. At the end of the supplementation period, no statistically significant differences were seen between the groups in relation to the mean body weight (group C = 1906 ± 23 g, group P = 1875 ± 14 g, p = 0.25), length, or head circumference. The incidence rates of necrotizing enterocolitis and late-onset sepsis were similar in the two groups. At the corrected GA of 41 weeks, there were no differences between the groups with respect to anthropometric measurements or body composition analysis.
  
  
  
  Preterm infants receiving Bifidobacterium supplements did not exhibit better postnatal growth compared with those who received placebo treatment. No adverse effects were associated with probiotic administration. Registered under ClinicalTrials.gov Identifier no. NCT01379417.
authors.affiliation: Department of Neonatology, Hôpital de la Croix Rousse, Hospices Civils de Lyon, F-69004 Lyon, France; Rhone-Alpes Human Nutrition Research Center, F-69310 Pierre-Bénite, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Hays
authors.affiliation: Department of Neonatology, Hôpital A. de Villeneuve, F-34090 Montpellier, France.
authors.forename: Aurélien
authors.initials: A
authors.lastname: Jacquot
authors.affiliation: Department of Neonatology, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69500 Bron, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Gauthier
authors.affiliation: CK Consulting, Ottrott, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Kempf
authors.affiliation: Department of Neonatology, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69500 Bron, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Beissel
authors.affiliation: Department of Neonatology, Hôpital A. de Villeneuve, F-34090 Montpellier, France.
authors.forename: Odile
authors.initials: O
authors.lastname: Pidoux
authors.affiliation: Department of Bacteriology, UMR5119, Université Montpellier 1, F-34090 Montpellier, France.
authors.forename: Estelle
authors.initials: E
authors.lastname: Jumas-Bilak
authors.affiliation: Department of Methodology and Statistical Analysis, Hospices Civils de Lyon, F-69003 Lyon, France.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Decullier
authors.affiliation: Nestlé France, Marne-la-Vallée, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Lachambre
authors.affiliation: Nestlé France, Marne-la-Vallée, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Beck
authors.affiliation: Department of Neonatology, Hôpital A. de Villeneuve, F-34090 Montpellier, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Cambonie
authors.affiliation: Department of Neonatology, Hôpital de la Croix Rousse, Hospices Civils de Lyon, F-69004 Lyon, France; Université Claude Bernard Lyon 1, F-69100 Villeurbanne, France.
authors.forename: Guy
authors.initials: G
authors.lastname: Putet
authors.affiliation: Department of Neonatology, Hôpital Femme-Mère-Enfant, Hospices Civils de Lyon, F-69500 Bron, France; Université Claude Bernard Lyon 1, F-69100 Villeurbanne, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Claris
authors.affiliation: Department of Neonatology, Hôpital de la Croix Rousse, Hospices Civils de Lyon, F-69004 Lyon, France; Rhone-Alpes Human Nutrition Research Center, F-69310 Pierre-Bénite, France; Université Claude Bernard Lyon 1, F-69100 Villeurbanne, France. Electronic address: jean-charles.picaud@chu-lyon.fr.
authors.forename: Jean-Charles
authors.initials: JC
authors.lastname: Picaud
mesh_terms: D000069982:Bifidobacterium animalis; D000069978:Bifidobacterium longum; D001724:Birth Weight; D001823:Body Composition; D004032:Diet; D004044:Dietary Proteins / Q000008:administration & dosage; D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000453:epidemiology*; D005243:Feces / Q000737:chemistry / Q000382:microbiology; D005260:Female; D005865:Gestational Age; D006801:Humans; D015994:Incidence; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D007234:Infant, Premature / Q000254:growth & development*; D019102:Infant, Very Low Birth Weight / Q000254:growth & development; D008297:Male; D008895:Milk, Human / Q000737:chemistry; D019936:Probiotics / Q000008:administration & dosage*; D011446:Prospective Studies; D018805:Sepsis / Q000453:epidemiology*; D016896:Treatment Outcome
chemical_list: D004044:Dietary Proteins
keywords: Gut microflora; Necrotizing enterocolitis; Prematurity; Safety; Sepsis