Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT
1 other identifier
interventional
225
1 country
1
Brief Summary
The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 16, 2014
September 1, 2014
1.2 years
May 20, 2014
September 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
baseline changes in pain score using Premature Infant Pain Profile
baseline and end of hospitalization, expected hospitalization 4 weeks
Secondary Outcomes (1)
Length of stay in days
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other Outcomes (1)
Neonatal Intensive Care Unit cost
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Study Arms (3)
osteopathic manipulative treatment
OTHERnewborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care
sham
OTHERnewborns will receive sham treatment for the entire period of hospitalization plus usual care
usual care
OTHERnewborns allocated in the usual care arm will receive standard care only
Interventions
Eligibility Criteria
You may qualify if:
- newborns born in the same hospital
- either gender
- diagnosis of any pathological/clinical medical condition
You may not qualify if:
- lack of guardian consent
- newborn transferred to/from other hospital
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pescara Civil Hospital
Pescara, 65121, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2014
First Posted
May 26, 2014
Study Start
June 1, 2014
Primary Completion
August 1, 2015
Study Completion
November 1, 2015
Last Updated
September 16, 2014
Record last verified: 2014-09