Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial

European Institute for Evidence Based Osteopathic Medicine690 enrolled

Overview

The use of complementary and alternative medicine in neonatal ward has been steadily rising during the last decade. This integrated medicine approach has been shown to be helpful to improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to premature infants to reduce the length of stay and to cope with clinical complications. Results from previous studies documented the positive association between OMT and shorter period of hospitalisation as well as improvement of clinical conditions. The aim of this nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in premature infants across 3 neonatal intensive care units (NICU).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

690

Conditions

Prematurity

Interventions

Eligibility

Sex: ALLMin age: 29 WeeksMax age: 37 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * preterm infants born at age between 29 and 37 weeks * osteopathic treatment performed \< 14 days after birth * preterms born in the same hospital Exclusion Criteria: * Gestational age \< 29 weeks * Gestational age \> 37 weeks * First OMT performed after 14 days from birth * genetic disorders * congenital disorders * cardiovascular abnormalities * proven or suspected necrotized enterocolitis with or without gastrointestinal perforation * proven or suspected abdominal obstruction * pre/post surgery patients * pneumoperitoneum * atelectasis * Newborn from an HIV seropositive/drug addicted mother * respiratory disorders * transferred to/from other hospital * admitted for preterminal comfort care (defined as neither intubation nor cardio-respiratory resuscitation)

Locations (3)

Monza Hospital

Monza, Lombardy, Italy

Macerata Hospital

Macerata, The Marches, Italy

Pescara hospital

Pescara, Italy