Effects of the Application of PIOMI in the Oral Feeding of Premature
NCT ID: NCT06395298
Last Updated: 2024-05-02
Study Results
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Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2023-02-13
2026-12-30
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* 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)
TREATMENT
QUADRUPLE
* Masking methodology:
The Sant Joan de Déu Hospital Neonatal Unit carries out its care activity under the NIDCAP model, which includes care centered on the user and the family/mother or caregiver.
Currently, the design of the neonatal unit has individual boxes for the family member, which will allow the intervention to be carried out, as well as the orientations carried out by the health personnel with privacy and thus avoiding the identification of the different intervention models.
For the realization of the blind, it is proposed to make two video capsules in which the activities to be carried out will be collected, both by the control group and the experimental group, interspersing in the case of the experimental the PIOMI activities with the basic nursing care without doing reference to the intervention model assigned in the recording. Access to the video will be in quick response code format.
Study Groups
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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.
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
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.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
29 Weeks
30 Weeks
ALL
No
Sponsors
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Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition
UNKNOWN
Nexe Foundation
UNKNOWN
University Ramon Llull
OTHER
Borja Institute of Bioethics
UNKNOWN
Institut de Recerca Sant Joan de Déu
UNKNOWN
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Principal Investigators
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Raquel García Ezquerra
Role: PRINCIPAL_INVESTIGATOR
Sant Joan de Déu Hospital
Vanesa Ejarque Marin
Role: PRINCIPAL_INVESTIGATOR
Sant Joan de Déu Hospital
Locations
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Raquel García Ezquerra
Barcelona, Catalonia, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Grassi R, Farina R, Floriani I, Amodio F, Romano S. Assessment of fetal swallowing with gray-scale and color Doppler sonography. AJR Am J Roentgenol. 2005 Nov;185(5):1322-7. doi: 10.2214/AJR.04.1114.
Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
Lessen BS. Premature infant oral motor intervention (PIOMI) translating interventional research into interdisciplinary practice [Internet]. Unpublished; 2012. Disponible en: http://dx.doi.org/10.13140/RG.2.1.3652.696
Shailaja S J, Jayashri S K. Comparative study on the effect of oral motor intervention protocols on oral motor skills of preterm infants from tertiary care hospital in metropolitan city: pilot study. Int J ContempPediatr [Internet]. 2020;7(7):1506.
Tian X, Yi LJ, Zhang L, Zhou JG, Ma L, Ou YX, Shuai T, Zeng Z, Song GM. Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1310. doi: 10.1097/MD.0000000000001310.
Pickler RH, Best A, Crosson D. The effect of feeding experience on clinical outcomes in preterm infants. J Perinatol. 2009 Feb;29(2):124-9. doi: 10.1038/jp.2008.140. Epub 2008 Oct 2.
Boiron M, Da Nobrega L, Roux S, Henrot A, Saliba E. Effects of oral stimulation and oral support on non-nutritive sucking and feeding performance in preterm infants. Dev Med Child Neurol. 2007 Jun;49(6):439-44. doi: 10.1111/j.1469-8749.2007.00439.x.
Lessen BS. Effect of Oral Stimulation on Feeding Progression in Preterm Infants. Adv Neonatal Care [Internet]. 2009 Aug [cited 2021 Feb 14];9(4):187. Available from: https://journals.lww.com/00149525-200908000-00021
Other Identifiers
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C.I.PIC-108-22
Identifier Type: -
Identifier Source: org_study_id
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