Effects of PIOMI on Oral Feeding of the Premature Infants

Feeding Disorder Neonatal Clinical Trial

— PIOMI2020  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04290338
• Other study ID #: PIOMI2020Policlinico
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: September 2020

Study information

• Verified date: February 2020
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Odoardo Picciolini, physiatrist
• Phone: 0255034354
• Email: odoardo.picciolini[@]policlinico.mi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 33 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder Neonatal

Intervention

Other:
• PIOMI
Intraoral and extraoral stimulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean volume	Mean volume of oral intake	7 days
Secondary	feeding efficiency	oral intake at day one and at day three	3 days
Secondary	achievement of full oral feeding	PMA on reaching full oral feeding	6 moths
Secondary	hospital stay time	days spending to the hospital	6 months
Secondary	transition time	transition times from the tube to full oral feeding	6 months