Raquel García Ezquerra
Barcelona, Catalonia, 08096, Spain
Location status: Recruiting
Location contact
Raquel García Ezquerra
CONTACT
Raquel García Ezquerra
PRINCIPAL_INVESTIGATOR
Vanesa Ejarque Marin
CONTACT
Vanesa Ejarque Marin
SUB_INVESTIGATOR
NCT Number: NCT06395298
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.
Interested in participating?
Request Info29 week–30 week
All sexes
Interventional
Not applicable
Barcelona, Catalonia, 08096, Spain
Location status: Recruiting
Raquel García Ezquerra
CONTACT
Raquel García Ezquerra
PRINCIPAL_INVESTIGATOR
Vanesa Ejarque Marin
CONTACT
Vanesa Ejarque Marin
SUB_INVESTIGATOR
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: PIOMI+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)
Other names: NIDCAP
Time frame: 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
Time frame: 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.
Time frame: Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks
Quantify the days from birth to hospital discharge.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Assess weight discharge day, up to 12 weeks
To estimate the existence of significant differences between the group that presented intervention and the control.
Time frame: Assess weight ten days at hospital discharge, up to 12 weeks
Differences between discharge and 10-day weights
Time frame: The researchers will administer Neonatal Oral-Motor Assessment Scale (NOMAS)last day of intervention(10 days)
The NOMAS tool consists of 29 items distributed in 3 domains:
To achieve the feasibility of the evaluation tools Neonatal Oral-Motor Assessment Scale (NOMAS), the percentage of responses obtained will be taken into account. As a descriptive data analysis tool, the International Business Machines (IBM)software, Statistical Package for Social Sciences(SPSS) version 19.0.1 and variance analysis program(ANOVA), will be used in the pre- and post-test comparative data analysis.
Time frame: The researchers will administer (EFS)last day of intervention (10 days)
The EFSA tool consists of 19 items distributed in 5 domains:
Regulation of breathing 5 items: The range is from 5 to 15 with 5 being the lowest score and 15 being the highest score
Oromotor function 4 items: The range is from 4 to 12 with 4 being the lowest score and 14 being the highest score
Swallowing-breathing coordination 4 items: The range is from 4 to 12 with 4 being the lowest score and 12 being the highest score
Attention when taking 2 items and stability: The range is from 2 to 6 with 2 being the lowest score and 6 being the highest score
Physiological 4 items: The range is from 4 to 12 with 4 being the lowest score and 12 being the highest score
To achieve the feasibility of the evaluation tools EFS, the percentage of responses obtained will be considered. As a descriptive data analysis tool, Statistical package for the social sciences version 19.0.1 and variance analysis program, will be used in the pre- and post-test comparative data analysis.
Contact information is provided by the study sponsor or research team.
Raquel García Equerra
CONTACT
Vanesa Ejarque Marin
CONTACT
Fundació Sant Joan de Déu
Other
Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
Acronym: PIOMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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