Are Newborns Conscious of the Placebo Effect? Result From an RCT in Osteopathy

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

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-04-30

Brief Summary

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Results from previous studies suggest the association between Osteopathic Manipulative Treatment (OMT) and length of stay (LOS) reduction in a population of preterm infants.

The primary objective of the present study is to evaluate the effectiveness of sham OMT in reducing LOS in a sample of preterm newborns, in order to investigate whether previous clinical results could be related to a hypothetical placebo effect.

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AVAILABLE

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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Sham OMT

patients under standard medical care plus sham OMT

Group Type EXPERIMENTAL

Sham Osteopathic Manipulative Treatment

Intervention Type OTHER

Patients from this group received sham 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 OTHER

Standard care

Intervention Type OTHER

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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Sham Osteopathic Manipulative Treatment

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

Intervention Type OTHER

Standard care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* preterm infants born at age between 29 and 37 weeks
* sham osteopathic treatment performed \< 14 days after birth
* preterm infants born in the same hospital

Exclusion Criteria

* gestational age \< 29, \> 37 weeks;
* sham 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