Effects of PIOMI on Oral Feeding of the Premature Infants | NCT04290338

Studies
Effects of PIOMI on Oral Feeding of the Premature Infants

NCT04290338

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Status

Unknown status

Last Update Posted

Feb 28, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Feeding Disorder Neonatal

Interventions

PIOMI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Aug 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Feb 24, 2020

First Submission Date that Met QC Criteria

Feb 27, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2020

Last Update Posted Date

Feb 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PIOMI Group	Experimental	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
Control Group	No Intervention	Patients in this group will receive classic care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PIOMI	Other	Intraoral and extraoral stimulation.	PIOMI Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
feeding efficiency	oral intake at day one and at day three	3 days
achievement of full oral feeding	PMA on reaching full oral feeding

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Weeks

Maximum Age

33 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Odoardo Picciolini, physiatrist	Contact	0255034354		odoardo.picciolini@policlinico.mi.it
Matteo Porro, physiatrist	Contact	0255034353		matteo.porro@policlinico.mi.it

Overall Officials

Name	Affiliation	Role
Odoardo Picciolini	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

all collected IPD may result in a publication.

Types

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

Time Frame

1 year

Access Criteria

Not provided

URL

Not provided