Effects of PIOMI on Oral Feeding of the Premature Infants (PIOMI2020)

February 27, 2020 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: PIOMI
Intraoral and extraoral stimulation.
No Intervention: Control Group
Patients in this group will receive classic care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean volume
Time Frame: 7 days
Mean volume of oral intake
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feeding efficiency
Time Frame: 3 days
oral intake at day one and at day three
3 days
achievement of full oral feeding
Time Frame: 6 moths
PMA on reaching full oral feeding
6 moths
hospital stay time
Time Frame: 6 months
days spending to the hospital
6 months
transition time
Time Frame: 6 months
transition times from the tube to full oral feeding
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Study Director: Odoardo Picciolini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIOMI2020Policlinico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD may result in a publication.

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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