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

Phase 4

Completed

• Conditions: Prematurity

• Registration Number: NCT01852500
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Study First Posted: 2013-05-13
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of sham OMT in reducing LOS	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Name	Time	Method
pre-post difference in weight gain	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Trial Locations

Locations (1)

Francesco Cerritelli; 🇮🇹 Pescara, PE, Italy