NCT03833635

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

February 6, 2019

Last Update Submit

March 21, 2019

Conditions

Premature InfantPhysiological Stress

Outcome Measures

Primary Outcomes (1)

  • heart rate

    measure of heart rate

    immediate

Secondary Outcomes (1)

  • oxygen saturation

    immediate

Study Arms (2)

OMT

EXPERIMENTAL
Other: osteopathic manipulative treatment

Control

PLACEBO COMPARATOR
Other: Sham

Interventions

osteopathic manipulative treatmentOTHER

OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect

OMT
ShamOTHER

the sham intervention consists in a stable skin-to-skin contact with the participant

Control

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm infants

You may not qualify if:

  • congenital/genetic disease
  • cardiovascular/neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chieti-Pescara

Chieti, 66100, Italy

RECRUITING

Buzzi hospital

Milan, 20154, Italy

RECRUITING

Related Publications (1)

  • Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.

    PMID: 32379655DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Manipulation, Osteopathicsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 7, 2019

Study Start

March 22, 2019

Primary Completion

June 30, 2019

Study Completion

September 30, 2019

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

IT(2)