A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms

Francesco Cerritelli, Gianfranco Pizzolorusso, Cinzia Renzetti, Vincenzo Cozzolino, Marianna D'Orazio, Mariacristina Lupacchini, Benedetta Marinelli, Alessandro Accorsi, Chiara Lucci, Jenny Lancellotti, Silvia Ballabio, Carola Castelli, Daniela Molteni, Roberto Besana, Lucia Tubaldi, Francesco Paolo Perri, Paola Fusilli, Carmine D'Incecco, Gina Barlafante, Francesco Cerritelli, Gianfranco Pizzolorusso, Cinzia Renzetti, Vincenzo Cozzolino, Marianna D'Orazio, Mariacristina Lupacchini, Benedetta Marinelli, Alessandro Accorsi, Chiara Lucci, Jenny Lancellotti, Silvia Ballabio, Carola Castelli, Daniela Molteni, Roberto Besana, Lucia Tubaldi, Francesco Paolo Perri, Paola Fusilli, Carmine D'Incecco, Gina Barlafante

Abstract

Background: Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes.

Materials and 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.

Trial registration: ClinicalTrials.gov NCT01645137.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow chart of the study…
Fig 1. Flow chart of the study selection.
Fig 2. Relationship between LOS and GA…
Fig 2. Relationship between LOS and GA by study group.
Mean total and 95% CI length of hospital stay (LOS) measured in days per gestational age (GA) measured in weeks. Groups are: control (red) and OMT (cyan). A linear quadratic effect of LOS on GA is showed in both groups but the use of OMT significantly reduced LOS along different GAs (up to 36 weeks) compared to control group.

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