Actively Recruiting

Phase Not Applicable
Age: 29Weeks - 30Weeks
All Genders
NCT06395298

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

Led by Fundació Sant Joan de Déu · Updated on 2024-05-02

35

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

Sponsors

F

Fundació Sant Joan de Déu

Lead Sponsor

S

Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 29Weeks - 30Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates born at the Sant Joan de Déu Hospital with gestational age between 29-30 weeks
  • Carry an external feeding device due to oral feeding difficulties
  • Considered clinically stable by the medical team
Not Eligible

You will not qualify if you...

  • Endotracheal intubation or use of high-flow ventilatory support
  • Receiving exclusive parenteral nutrition
  • Hyporeactive due to sedative drug use
  • Prematurity associated with other conditions like syndromes, acquired brain damage, gastrointestinal, airway, or craniofacial malformations

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Raquel García Ezquerra

Barcelona, Catalonia, Spain, 08096

Actively Recruiting

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Research Team

R

Raquel García Equerra

CONTACT

V

Vanesa Ejarque Marin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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