---
title: Effects of OMT on Premature Physiological Parameters
nct_id: NCT03833635
overall_status: UNKNOWN
phase: NA
sponsor: Come Collaboration
study_type: INTERVENTIONAL
primary_condition: Premature Infant
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03833635.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03833635"
ct_last_update_post_date: 2019-03-25
last_seen_at: "2026-05-12T06:00:18.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of OMT on Premature Physiological Parameters

**Official Title:** Effects of OMT on Premature Physiological Parameters: a RCT

**NCT ID:** [NCT03833635](https://clinicaltrials.gov/study/NCT03833635)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Come Collaboration
- **Collaborators:** Vittore Buzzi Children's Hospital
- **Conditions:** Premature Infant, Physiological Stress
- **Start Date:** 2019-03-22
- **Completion Date:** 2019-09-30
- **CT.gov Last Update:** 2019-03-25

## 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

## Eligibility

- **Maximum age:** 2 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* preterm infants

Exclusion Criteria:

* congenital/genetic disease
* cardiovascular/neurological disease
```

## Arms

- **OMT** (EXPERIMENTAL)
- **Control** (PLACEBO_COMPARATOR)

## Interventions

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

## Primary Outcomes

- **heart rate** _(time frame: immediate)_ — measure of heart rate

## Secondary Outcomes

- **oxygen saturation** _(time frame: immediate)_

## Locations (2)

- University of Chieti-Pescara, Chieti, Italy — _RECRUITING_
- Buzzi hospital, Milan, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of chieti-pescara|chieti||italy` — added _(2026-05-12)_
- `locations.buzzi hospital|milan||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03833635.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03833635*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*