Effects of PIOMI on Oral Feeding of the Premature Infants

Not Applicable

• Conditions: Feeding Disorder Neonatal
• Interventions: Other: PIOMI

• Registration Number: NCT04290338
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-02-28
• Last Update Posted: 2020-02-28
• Study Start: 2020-03
• Primary Completion: 2020-08
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PIOMI Group	PIOMI	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.

Primary Outcome Measures

Name	Time	Method
Mean volume	7 days	Mean volume of oral intake

Secondary Outcome Measures

Name	Time	Method
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