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Status unknownNCT03833635Updated Mar 25, 2019

Effects of OMT on Premature Physiological Parameters

An interventional study of osteopathic manipulative treatment and Sham in Premature Infant and Physiological Stress, sponsored by Come Collaboration. Status unknown at 2 sites in Italy. Open to participants aged Up to 2 Months. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by Come Collaboration · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
Up to 2 Months
Sex
All
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Study 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

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Conditions studied

  • Premature Infant
  • Physiological Stress

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03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 100 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Come Collaboration is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 2 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • preterm infants

Exclusion criteria

Exclusion Criteria:

  • congenital/genetic disease
  • cardiovascular/neurological disease
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    OMT

    Other: osteopathic manipulative treatment

  • Placebo comparator
    Control

    Other: Sham

Interventions

  • Otherosteopathic manipulative treatment

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

  • OtherSham

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

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What researchers measure

Primary outcomes

  1. heart rate

    measure of heart rate

    Time frame: immediate

Secondary outcomes

  1. oxygen saturation

    measure of oxygen

    Time frame: immediate

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Study locations

2 of 2 sites recruiting
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References and documents

Publications

  • 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. PubMed 32379655 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03833635
Lead sponsor
Come Collaboration
Collaborators
Vittore Buzzi Children's Hospital
Responsible party
Sponsor
First posted
Feb 7, 2019
Start date
Mar 22, 2019
Primary completion
Jun 30, 2019 (estimated)
Completion
Sep 30, 2019 (estimated)
Last update
Mar 25, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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