Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

European Institute for Evidence Based Osteopathic Medicine225 enrolled

Overview

The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Prematurity

Interventions

osteopathic manipulative treatmentOTHER

sham therapyOTHER

usual careOTHER

Eligibility

Sex: ALLMin age: 26 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * newborns born in the same hospital * either gender * diagnosis of any pathological/clinical medical condition Exclusion Criteria: * lack of guardian consent * newborn transferred to/from other hospital * lack of any of the inclusion criteria

Locations (1)

Pescara Civil Hospital

Pescara, Italy

RECRUITING

Outcomes

Primary Outcomes

baseline changes in pain score using Premature Infant Pain Profile

Time frame: baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcomes

Length of stay in days

Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Central Contacts

Francesco Cerritelli

CONTACT

+393394332801 francesco.cerritelli@ebom.it

Data from ClinicalTrials.gov

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