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Effects of PIOMI on Oral Feeding of the Premature Infants

NCT ID: NCT04290338

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-09-30

Brief Summary

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Randomized controlled clinical trial aimed at evaluating the effects of the "Premature infant oral motor intervention" method on the oral feeding skills of the premature infants.

Detailed Description

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Numerous evidences emerge from the literature review on the usefulness of the PIOMI method to improve food skills in the premature infant. The goal of this study is to evaluate the effects of the PIOMI method by adding the gustatory stimulation to the original protocol.

Conditions

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Feeding Disorder Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT characterized by the comparison between two groups (treated / untreated)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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PIOMI Group

Patients in this group will receive the intraoral and extraoral stimulations provided by the PIOMI protocol. These stimulations will last 5 minutes and will be performed once a day for 7 consecutive days for each patient.

Group Type EXPERIMENTAL

PIOMI

Intervention Type OTHER

Intraoral and extraoral stimulation.

Control Group

Patients in this group will receive classic care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PIOMI

Intraoral and extraoral stimulation.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* gestational age at birth between 25-33 weeks;
* clinical stability;
* possible presence of nasogastric or oro-gastric tube;
* non-invasive respiratory support (oxygen, high flows)

Exclusion Criteria

* gestational age \<25 weeks or\> 33 weeks
* absence of clinical stability
* invasive respiratory support (CPAP)
* previous surgical interventions
* ongoing infections
* congenital and / or chromosomal diseases
* brain, metabolic, cardiac, gastrointestinal diseases
* presence of bronchopulmonary dysplasia
Minimum Eligible Age

25 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Odoardo Picciolini

Role: STUDY_DIRECTOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Central Contacts

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Odoardo Picciolini, physiatrist

Role: CONTACT

Phone: 0255034354

Email: [email protected]

Matteo Porro, physiatrist

Role: CONTACT

Phone: 0255034353

Email: [email protected]

Other Identifiers

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PIOMI2020Policlinico

Identifier Type: -

Identifier Source: org_study_id