Effects of PIOMI on Oral Feeding of the Premature Infants

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04290338

Acronym

PIOMI2020

Enrollment

Registered

2020-02-28

Start date

2020-03-31

Completion date

2020-09-30

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Disorder Neonatal

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.

Interventions

OTHERPIOMI

Intraoral and extraoral stimulation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

25 Weeks to 33 Weeks

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactOdoardo Picciolini, physiatrist

odoardo.picciolini@policlinico.mi.it0255034354

Backup ContactMatteo Porro, physiatrist

matteo.porro@policlinico.mi.it0255034353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026