Effects of the Application of PIOMI in the Oral Feeding of Premature
- Conditions
- DysphagiaDisorder; Feeding, NewbornPremature
- Interventions
- Other: Experimental group PIOMIOther: Control group NIDCAP
- Registration Number
- NCT06395298
- Lead Sponsor
- Fundació Sant Joan de Déu
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 35
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group PIOMI Experimental group PIOMI Participants will receive: 1. The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU) .The nurse providing direct care to the patient and family, will carry out the relevant care of the patient. 2. The Premature Oral Motor Intervention (PIOMI) .The family will apply the PIOMI , 7 activities are intraoral stimulation for 10 consecutive days, twice a day, 5 minutes. 3. Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day 4. Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day. Control Group NIDCAP Control group NIDCAP Participants will receive : 1.The traditional intervention Newborn Individualized Development Care and Assessment Program (NIDCAP) model of the Neonatal Intensive Care Unit (NICU).The nurse providing direct care to the patient and family, will carry out the relevant care of the patient. 3.Gustatory stimulation technique:the application of oropharyngeal colostrum, a 0.5 milliliter twice a day 4.Olfactory stimulation Technique:A swab is moistened in breast milk and placed near the nose for one minute, twice a day.
- Primary Outcome Measures
Name Time Method Time to remove the external feeding device Days of life of the baby when the external feeding device is removed assessed up to 30 days To perform a proper calculation, the investigator must quantify the days of life in which the feeding device is placed and the date of effective removal
- Secondary Outcome Measures
Name Time Method Deferred breastfeeding patients after hospital discharge Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge
Weight ten days at hospital discharge Assess weight ten days at hospital discharge, up to 12 weeks Differences between discharge and 10-day weights
Formula feeding patients after hospital discharge Number of patients who are formula feeding after hospital discharge, up to 12 weeks Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.
Weight at hospital discharge Assess weight discharge day, up to 12 weeks To estimate the existence of significant differences between the group that presented intervention and the control.
Volume of intake at discharge Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks To perform a proper calculation, the investigator must quantify the volumen of milk in millilitres from the day of device removal until hospital discharge.
Hospitalization days Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks Quantify the days from birth to hospital discharge.
Breastfeeding patients after hospital discharge Number of patients who are breast-feeding after hospital discharge up to 12 weeks Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.
Trial Locations
- Locations (1)
Raquel García Ezquerra
🇪🇸Barcelona, Catalonia, Spain