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

European Institute for Evidence Based Osteopathic Medicine250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

250

Conditions

Prematurity

Interventions

Sham Osteopathic Manipulative TreatmentOTHER

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

Standard careOTHER

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

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 * 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.

Locations (1)

Francesco Cerritelli

Pescara, PE, Italy

Outcomes

Primary Outcomes

Evaluate the effectiveness of sham OMT in reducing LOS

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

Secondary Outcomes

pre-post difference in weight gain

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

Data from ClinicalTrials.gov

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