Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT06395298
Recruiting Not applicable

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

NCT06395298 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundació Sant Joan de Déu
Phase
Not applicable
Started
2023-02-13
Last updated
2024-05-02

Condition(s) studied

DysphagiaDisorder; Feeding, NewbornPremature

Investigational drug(s) / intervention(s)

Experimental group PIOMIControl group NIDCAP

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

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)

Study 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

Sex
ALL
Min age
29 Weeks
Max age
30 Weeks
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Raquel García Ezquerra Barcelona Catalonia Recruiting

More Fundació Sant Joan de Déu trials in Spain

Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury. Starting soon
Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder and Feeding Difficulties Recruiting
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development Recruiting
ePlatform for Promoting Health in Schools Recruiting
Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers Active, not recruiting

Other trials for the same condition

Evaluation of the Functional Status of Jejunoplasty and Coloplasty and Its Impact on Quality of Life (CEREC) Recruiting
Masseter and Rectus Femoris Ultrasound for Dysphagia and Sarcopenia in Critically Ill Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06395298 on ClinicalTrials.gov ↗ ← All trials in Spain