Effect of Osteopathic Manipulative Treatment on Length of Stay in Preterms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvement in several clinical outcomes. The aim of the present study is to show the effect of OMT on LOS in a sample of premature infants.

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Detailed Description

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OMT

patients under standard medical care plus OMT.

Group Type EXPERIMENTAL

osteopathic manipulative treatment

Intervention Type OTHER

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

Control

patients under standard medical care plus only osteopathic evaluation

Group Type NO_INTERVENTION

Usual care

Intervention Type PROCEDURE

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Interventions

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osteopathic manipulative treatment

Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.

Intervention Type OTHER

Usual care

Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Intervention Type PROCEDURE

Eligibility Criteria

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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, \> 37 weeks;
* osteopathic treatment performed \> 14 days after birth;
* newborn transferred to/from other hospital;
* newborn from to HIV seropositive and/or drug addict mother;
* newborn with genetic disorders, congenital abnormalities, cardiovascular abnormalities, neurological disorders, proven or suspected necrotizing enterocolitis with or without gastrointestinal perforation, proven or suspected abdominal obstruction, pre- and/or post-surgery patients, pneumoperitoneum and/or atelectasis.

Minimum Eligible Age

29 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes