Clinical trial NCT06395298: Effects of the Application of PIOMI in the Oral Feeding of Premature
Official title: Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysphagia
Disorder; Feeding, Newborn
Premature
Keywords: Swallowing
Swallowing disorders
Nutritional support
Feeding disorders
Preterm
Neonates
Sucking Behavior
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition
name: Nexe Foundation
name: University Ramon Llull
name: Borja Institute of Bioethics
name: Institut de Recerca Sant Joan de Déu
First posted: 2024-05-02
Enrollment: 35
Sex: ALL
Minimum age (years): 29
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Assignment: Random and parallel using the OxMaR (Oxford Minimization and Randomization) software
* Age range: 29-30 gestational weeks, both sexes will participate

  * Control group:

Will receive the traditional intervention model of the Neonatal Intensive Care Unit (non-nutritive suction and kangaroo method)

o Experimental group: Application of the PIOMI (Premature Infant Oral Motor Intervention) protocol, for 5 minutes twice a day, in a period of 10 days o Both groups will receive gustatory and olfactory stimulation

* Intervention model: Parallel assignment
* Description of the intervention model: Comparison of two groups, treated with the application of the care model in the NICU (Neonatal Intensive Care Unit) and the application of PIOMI (Premature Infant Oral Motor Intervention)
Primary purpose: TREATMENT

Brief 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.

Detailed description: Prematurity is one of the most common factors affecting the development of oromotor skills, interfering with feeding. The most common clinical manifestation is uncoordinated sucking-breathing-swallowing cycle.

The incidence of oropharyngeal dysphagia in paediatrics is estimated at 10.40%, doubling in preterm infants weighing less than 1500 grams. The aetiological distribution of swallowing disorders in the neonatal age is highly variable, as is their clinical presentation. Current literature reflects the impact of the use of an external feeding device on the quality of life of the patient-family, as well as the increased health care costs due to prolonged hospitalisation, emergencies for device removal, consumables and enteral nutrition.

Current health models are based on prevention, hence the importance of establishing early protocols for assessment, diagnosis and intervention. The main difficulty in neonatal intensive care units is the loss of opportunity for oral feeding and the absence of standardised protocols, as there is great controversy regarding the intervention techniques that should be applied to promote the development of oral-motor skills.The PIOMI is the intervention model that currently presents the greatest scientific production, the results obtained in the studies carried out show a high success rate in relation to the initiation of oral feeding in preterm infants, as well as the maintenance of high breastfeeding rates at the time of hospital discharge and at 10 days, in compliance with the standards of the World Health Organisation (WHO).

At present, there are study designs of PIOMI, combined with olfactory-gustatory stimulation, but the latter is not specified as an oropharyngeal colostrum technique, which is currently indicated in the therapeutic guidelines, nor is the protocolised nursing care model described, an aspect that is of great importance because each hospital centre offers different care depending on whether or not the model is based on the individualised assessment and care programme for the development of the newborn.

This research aims to evaluate these aspects by means of a randomised double-blind parallel allocation clinical trial using Oxford Minimization and Randomization (OxMaR) software, to be carried out at the Hospital Sant Joan de Déu in Barcelona, in the neonatal intensive care unit in the period November 2023-2026. The sample size is n=35 preterm infants of gestational age 29-30+6.

The control group will follow the NIDCAP care model and the experimental group will apply the PIOMI+NIDCAP protocol for 5 minutes twice a day for 10 days, with olfactory stimulation and oropharyngeal colostrum for both groups.

The family will apply the intervention by accessing a quick response code with an information capsule according to the assigned group.

To identify factors, sociodemographic and health variables, process variables and outcome variables will be selected using the Neonatal Oral-motor Assessment Scale (NOMAS), Early Feeding Skills Assessment (EFSA) and pre- and post-tests will be analysed using variance analysis program (ANOVA) and statistical package for the social sciences (SPSS)

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).

Primary outcomes:
measure: Time to remove the external feeding device
timeFrame: Days of life of the baby when the external feeding device is removed assessed up to 30 days
Secondary outcomes:
measure: Volume of intake at discharge
timeFrame: Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks
measure: Hospitalization days
timeFrame: Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks
measure: Breastfeeding patients after hospital discharge
timeFrame: Number of patients who are breast-feeding after hospital discharge up to 12 weeks
measure: Deferred breastfeeding patients after hospital discharge
timeFrame: Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks
measure: Formula feeding patients after hospital discharge
timeFrame: Number of patients who are formula feeding after hospital discharge, up to 12 weeks
measure: Weight at hospital discharge
timeFrame: Assess weight discharge day, up to 12 weeks
measure: Weight ten days at hospital discharge
timeFrame: Assess weight ten days at hospital discharge, up to 12 weeks
Other outcomes:
measure: Results of the items of the evaluation Neonatal Oral-Motor Assessment Scale (NOMAS)
timeFrame: The researchers will administer Neonatal Oral-Motor Assessment Scale (NOMAS)last day of intervention(10 days)
measure: Results of the items of the evaluation Early Feeding Skills (EFS)
timeFrame: The researchers will administer (EFS)last day of intervention (10 days)
Locations:
city: Barcelona
country: Spain
facility: Raquel García Ezquerra
state: Catalonia
Study officials:
affiliation: Sant Joan de Déu Hospital
name: Raquel García Ezquerra
role: PRINCIPAL_INVESTIGATOR
affiliation: Sant Joan de Déu Hospital
name: Vanesa Ejarque Marin
role: PRINCIPAL_INVESTIGATOR
References:
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