Effects of the Application of PIOMI in the Oral Feeding of Premature

Summary

The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.

Conditions

• Dysphagia
• Disorder; Feeding, Newborn
• Premature

Interventions

OTHER

Experimental group PIOMI

A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)+PIOMI

OTHER

Control group NIDCAP

A group treated with the application of the care model Newborn Individualized Development Care and Assessment Program (NIDCAP) in the Neonatal Intensive Unit Care (NICU)

Sponsors & Collaborators

• Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition

  collaborator UNKNOWN

• Nexe Foundation

  collaborator UNKNOWN

• University Ramon Llull

  collaborator OTHER

• Borja Institute of Bioethics

  collaborator UNKNOWN

• Institut de Recerca Sant Joan de Déu

  collaborator UNKNOWN

• Fundació Sant Joan de Déu

  lead OTHER

Principal Investigators

• Raquel García Ezquerra · Sant Joan de Déu Hospital

• Vanesa Ejarque Marin · Sant Joan de Déu Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

29 Weeks

Max Age

30 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-13

Primary Completion

2026-06-03

Completion

2026-12-30

Countries

• Spain

Study Locations