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

Prematurity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852500
• Other study ID #: NEO-Plac 01
• Secondary ID: NEO-Plac 01
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2013
• Last updated: May 9, 2013
• Start date: November 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2013
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 29 Weeks to 37 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Sham Osteopathic Manipulative Treatment
Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
• Standard care
Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.

Locations

Country	Name	City	State
Italy	Francesco Cerritelli	Pescara	PE

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Cerritelli F, Pizzolorusso G, Ciardelli F, La Mola E, Cozzolino V, Renzetti C, D'Incecco C, Fusilli P, Sabatino G, Barlafante G. Effect of osteopathic manipulative treatment on length of stay in a population of preterm infants: a randomized controlled trial. BMC Pediatr. 2013 Apr 26;13:65. doi: 10.1186/1471-2431-13-65. — View Citation

Pizzolorusso G, Turi P, Barlafante G, Cerritelli F, Renzetti C, Cozzolino V, D'Orazio M, Fusilli P, Carinci F, D'Incecco C. Effect of osteopathic manipulative treatment on gastrointestinal function and length of stay of preterm infants: an exploratory study. Chiropr Man Therap. 2011 Jun 28;19(1):15. doi: 10.1186/2045-709X-19-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	pre-post difference in weight gain		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No