RecruitingNot ApplicableNCT06395298

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

Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial


Sponsor

Fundació Sant Joan de Déu

Enrollment

35 participants

Start Date

Feb 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 29 WeeksMax Age: 30 Weeks

Inclusion Criteria1

  • Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.

Exclusion Criteria4

  • Endotracheal intubation or high-flow ventilatory support.
  • Exclusive parenteral nutrition.
  • Hyporeactive due to the use of sedative drugs.
  • Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).

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Interventions

OTHERExperimental 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

OTHERControl 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)


Locations(1)

Raquel García Ezquerra

Barcelona, Catalonia, Spain

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NCT06395298


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