Effects of the Application of PIOMI in the Oral Feeding of Premature
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-30
SponsorFundació Sant Joan de Déu
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Experimental group PIOMI
- Control group NIDCAP
Treatment groups
35 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fundació Sant Joan de Déu
Lead sponsor
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Collaborator
Nexe Foundation
Collaborator
University Ramon Llull
Collaborator
Borja Institute of Bioethics
Collaborator
Institut de Recerca Sant Joan de Déu
Collaborator
Source ClinicalTrials.gov