Clinical Trials Logo
  1. Home
  2. Premature Infant
  3. NCT03833635
  4. Details
NCT03833635 Clinical Trial

Effects of OMT on Premature Physiological Parameters

Premature Infant Clinical Trial

Official title:
Effects of OMT on Premature Physiological Parameters: a RCT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03833635
Other study ID # COME-01-18
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2019
Est. completion date September 30, 2019

Study information
Verified date March 2019
Source Come Collaboration
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Months
Eligibility Inclusion Criteria:

- preterm infants

Exclusion Criteria:

- congenital/genetic disease

- cardiovascular/neurological disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• osteopathic manipulative treatment
OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
• Sham
the sham intervention consists in a stable skin-to-skin contact with the participant

Locations
Country Name City State
Italy University of Chieti-Pescara Chieti
Italy Buzzi hospital Milan

Sponsors (2)
Lead Sponsor Collaborator
Come Collaboration Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate measure of heart rate immediate
Secondary oxygen saturation measure of oxygen immediate
See also
  Status Clinical Trial Phase
Terminated NCT02550054 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Completed NCT03827252 - Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
Active, not recruiting NCT03345069 - Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
Completed NCT04067206 - The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants N/A
Completed NCT03911674 - Effects of Oral Stimulation in Preterm Infants Phase 3
Completed NCT03324126 - Individualized Fortification of Breast Milk N/A
Completed NCT03704012 - Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas) N/A
Active, not recruiting NCT03241082 - Ultrasound Assessment of BC in the NICU
Completed NCT03701906 - Effect of a Mixture of New Probiotic Strains in Preterm Infants N/A
Completed NCT02133716 - Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm Phase 4
Not yet recruiting NCT05543005 - Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants N/A
Recruiting NCT03852641 - Feeding Premature Infants During Non-invasive Respiratory Support N/A
Active, not recruiting NCT03423914 - Efficacy of Expressive Writing in Mothers of Preterm Infants N/A
Recruiting NCT04648787 - A Study of Family-integrated Care for Reducing Uncertainty N/A
Recruiting NCT04866342 - Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor N/A
Not yet recruiting NCT02601872 - Erythropoietin in Premature Infants to Prevent Encephalopathy Phase 2
Not yet recruiting NCT02534090 - Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy N/A
Recruiting NCT06212427 - Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs) N/A
Suspended NCT03939169 - The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP) N/A
Completed NCT03683316 - Work of Breathing and Kangaroo Mother Care