Feeding Disorder NeonatalPIOMI2020NCT04290338
Effects of PIOMI on Oral Feeding of the Premature Infants
A study testing PIOMI in people with Feeding Disorder Neonatal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 33 weeks
- Conditions the study is for
- Feeding Disorder Neonatal
- What is being tested?
- PIOMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Feeding Disorder Neonatal
- Being tested
- PIOMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIOMIOther
Intraoral and extraoral stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PIOMI |
| Control Group | No intervention | Patients in this group will receive classic care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean volume
Mean volume of oral intake
Measured: 7 days
Secondary outcomes (4)
feeding efficiency
oral intake at day one and at day three
Measured: 3 days
achievement of full oral feeding
PMA on reaching full oral feeding
Measured: 6 moths
hospital stay time
days spending to the hospital
Measured: 6 months
transition time
transition times from the tube to full oral feeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding Disorder NeonatalStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT characterized by the comparison between two groups (treated / untreated)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Odoardo Picciolini, Study director, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290338
- Sponsor's protocol ID
- PIOMI2020Policlinico
- Acronym
- PIOMI2020
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD may result in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Premature Infant Oral Motor Intervention on the Oral Feeding Skills of the Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04290338
- Acronym / sponsor ID
- PIOMI2020 / PIOMI2020Policlinico
- Conditions
- Feeding Disorder Neonatal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RCT characterized by the comparison between two groups (treated / untreated)
| Arm | Type | Receives |
|---|---|---|
| PIOMI Group | Experimental | Other: PIOMIPatients 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. |
| Control Group | No intervention | –Patients in this group will receive classic care. |
Who may qualify
- Ages
- 25 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- gestational age <25 weeks or> 33 weeks
- absence of clinical stability
- invasive respiratory support (CPAP)
- previous surgical interventions
- ongoing infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIOMIIntraoral and extraoral stimulation. | Other | PIOMI Group |
Primary outcome
Mean volume
Time frame: 7 days
Mean volume of oral intake
4 secondary outcomes
feeding efficiency
Time frame: 3 days
achievement of full oral feeding
Time frame: 6 moths
hospital stay time
Time frame: 6 months
transition time
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Yes. all collected IPD may result in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odoardo Picciolini study director
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Questions about this trial
What is this clinical trial studying?
A study testing PIOMI in people with Feeding Disorder Neonatal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odoardo Picciolini, physiatrist (0255034354, odoardo.picciolini@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean volume (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.