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Search / Trial NCT06395298

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

Launched by FUNDACIÓ SANT JOAN DE DÉU · Apr 29, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Swallowing Swallowing Disorders Nutritional Support Feeding Disorders Preterm Neonates Sucking Behavior

ClinConnect Summary

This clinical trial is studying a new approach to help premature babies who have trouble feeding, a condition known as dysphagia. The researchers want to see if using a special technique called the Premature Oral Motor Intervention (PIOMI), along with a supportive care program for newborns, can help these babies feed on their own more safely and effectively. The goal is to see if this combined approach allows babies to stop using feeding tubes while still getting the nutrition they need, and if it helps them breastfeed before they leave the hospital.

To be eligible for this trial, babies must be born between 29 and 30 weeks of gestation and be receiving feeding through a tube because they have difficulty feeding orally. They should also be stable enough for participation, meaning their overall health is not seriously compromised. However, babies who are on certain types of breathing support or have other serious health issues won’t be included. For families participating, the trial will provide a structured approach to help their babies learn to feed better, while closely monitoring their progress and safety during the process.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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).

About Fundació Sant Joan De Déu

Fundació Sant Joan de Déu is a distinguished clinical trial sponsor dedicated to advancing medical research and improving patient care. Affiliated with the renowned Sant Joan de Déu Hospital in Barcelona, the foundation focuses on innovative healthcare solutions, fostering collaboration among healthcare professionals, researchers, and institutions. With a commitment to ethical practices and patient-centered approaches, Fundació Sant Joan de Déu supports a diverse range of clinical studies aimed at addressing complex health challenges and enhancing therapeutic outcomes. Through its comprehensive research programs, the foundation strives to contribute significantly to the field of medicine and the well-being of communities.

Locations

Barcelona, Catalonia, Spain

Patients applied

0 patients applied

Trial Officials

Raquel García Ezquerra

Principal Investigator

Sant Joan de Déu Hospital

Vanesa Ejarque Marin

Principal Investigator

Sant Joan de Déu Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported