Effects of PIOMI on Oral Feeding of the Premature Infants (PIOMI2020)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Unknown

Conditions: Feeding Disorder Neonatal

Treatments: Other: PIOMI

Study type: Interventional

Funder types: Other

Identifiers

NCT04290338

PIOMI2020Policlinico

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 33 weeks old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

PIOMI Group

Experimental group

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.

Treatment:

Other: PIOMI

Control Group

No Intervention group

Description:

Patients in this group will receive classic care.