Back to resultsEffects of PIOMI on Oral Feeding of the Premature Infants (PIOMI2020)
Primary Purpose
Feeding Disorder Neonatal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PIOMI
Sponsored by
About this trial
This is an interventional supportive care trial for Feeding Disorder Neonatal
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PIOMI Group
Control Group
Arm Description
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.
Patients in this group will receive classic care.
Outcomes
Primary Outcome Measures
Mean volume
Mean volume of oral intake
Secondary Outcome Measures
feeding efficiency
oral intake at day one and at day three
achievement of full oral feeding
PMA on reaching full oral feeding
hospital stay time
days spending to the hospital
transition time
transition times from the tube to full oral feeding
Full Information
NCT ID
NCT04290338
First Posted
February 24, 2020
Last Updated
February 27, 2020
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1. Study Identification
Unique Protocol Identification Number
NCT04290338
Brief Title
Effects of PIOMI on Oral Feeding of the Premature Infants
Acronym
PIOMI2020
Official Title
Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Disorder Neonatal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT characterized by the comparison between two groups (treated / untreated)
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PIOMI Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients in this group will receive classic care.
Intervention Type
Other
Intervention Name(s)
PIOMI
Intervention Description
Intraoral and extraoral stimulation.
Primary Outcome Measure Information:
Title
Mean volume
Description
Mean volume of oral intake
Time Frame
7 days
Secondary Outcome Measure Information:
Title
feeding efficiency
Description
oral intake at day one and at day three
Time Frame
3 days
Title
achievement of full oral feeding
Description
PMA on reaching full oral feeding
Time Frame
6 moths
Title
hospital stay time
Description
days spending to the hospital
Time Frame
6 months
Title
transition time
Description
transition times from the tube to full oral feeding
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odoardo Picciolini, physiatrist
Phone
0255034354
Email
odoardo.picciolini@policlinico.mi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Matteo Porro, physiatrist
Phone
0255034353
Email
matteo.porro@policlinico.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odoardo Picciolini
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD may result in a publication.
IPD Sharing Time Frame
1 year
Learn more about this trial
Effects of PIOMI on Oral Feeding of the Premature Infants
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