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

NCT01852500 | Completed Phase 4

• 1 other identifier: NEO-Plac 01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• pre-post difference in weight gain

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

Study Arms (2)

Sham OMT

EXPERIMENTAL

patients under standard medical care plus sham OMT

Other: Sham Osteopathic Manipulative Treatment

Control

OTHER

patients under standard medical care plus only osteopathic evaluation

Other: Standard care

Interventions

Sham Osteopathic Manipulative Treatment OTHER

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

Sham OMT

Standard care OTHER

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

Control

Eligibility Criteria

• Age: 29 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute for Evidence Based Osteopathic Medicine: lead

Study Sites (1)

Francesco Cerritelli

Pescara, PE, 65124, Italy

Location

Related 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.

  PMID: 23622070 BACKGROUND

• 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.

  PMID: 21711535 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Francesco Cerritelli, DO, MS

  European Institute for Evidence Based Osteopathic Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 13, 2013
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

IT (1)