title: A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.
abstract: BACKGROUND
  Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.
  
  
  METHODS
  The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups.
  
  
  RESULTS
  A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention.
  
  
  CONCLUSIONS
  Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.
authors.affiliation: Clinical-based Human Research Department, Centre for Osteopathic Medicine-C.O.ME. Collaboration, Pescara, Italy; Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Cerritelli
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Pizzolorusso
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: Renzetti
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Cozzolino
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Marianna
authors.initials: M
authors.lastname: D'Orazio
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Mariacristina
authors.initials: M
authors.lastname: Lupacchini
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Benedetta
authors.initials: B
authors.lastname: Marinelli
authors.affiliation: Clinical-based Human Research Department, Centre for Osteopathic Medicine-C.O.ME. Collaboration, Pescara, Italy; Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Accorsi
authors.affiliation: Clinical-based Human Research Department, Centre for Osteopathic Medicine-C.O.ME. Collaboration, Pescara, Italy; Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Lucci
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Jenny
authors.initials: J
authors.lastname: Lancellotti
authors.affiliation: Neonatal Intensive Care Unit-Desio Public Hospital, Desio, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Ballabio
authors.affiliation: Neonatal Intensive Care Unit-Desio Public Hospital, Desio, Italy.
authors.forename: Carola
authors.initials: C
authors.lastname: Castelli
authors.affiliation: Neonatal Intensive Care Unit-Desio Public Hospital, Desio, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Molteni
authors.affiliation: Neonatal Intensive Care Unit-Desio Public Hospital, Desio, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Besana
authors.affiliation: Neonatal Intensive Care Unit-Macerata Public Hospital, Macerata, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Tubaldi
authors.affiliation: Neonatal Intensive Care Unit-Macerata Public Hospital, Macerata, Italy.
authors.forename: Francesco Paolo
authors.initials: FP
authors.lastname: Perri
authors.affiliation: Neonatal Intensive Care Unit-Pescara Public Hospital, Pescara, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Fusilli
authors.affiliation: Neonatal Intensive Care Unit-Pescara Public Hospital, Pescara, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Incecco
authors.affiliation: Accademia Italiana Osteopatia Tradizionale, Pescara, Italy.
authors.forename: Gina
authors.initials: G
authors.lastname: Barlafante
mesh_terms: D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D007902:Length of Stay / Q000191:economics*; D008297:Male; D026301:Manipulation, Osteopathic / Q000191:economics / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome; D015430:Weight Gain