Effects of the Application of PIOMI in the Oral Feeding of Premature
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental group PIOMI, Control group NIDCAP.
- Who it may be relevant to
- Registry conditions: Dysphagia, Disorder; Feeding, Newborn, Premature. Basic parameters: 29 Weeks — 30 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
Overview
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)
Interventions
- Other 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 - Other 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)
Primary outcome measures
- Time to remove the external feeding device [Time frame: Days of life of the baby when the external feeding device is removed assessed up to 30 days]
Secondary outcome measures (7)
- Volume of intake at discharge [Time frame: Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks]
- Hospitalization days [Time frame: Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks]
- Breastfeeding patients after hospital discharge [Time frame: Number of patients who are breast-feeding after hospital discharge up to 12 weeks]
- Deferred breastfeeding patients after hospital discharge [Time frame: Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks]
- Formula feeding patients after hospital discharge [Time frame: Number of patients who are formula feeding after hospital discharge, up to 12 weeks]
- Weight at hospital discharge [Time frame: Assess weight discharge day, up to 12 weeks]
- Weight ten days at hospital discharge [Time frame: Assess weight ten days at hospital discharge, up to 12 weeks]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Raquel García Ezquerra — Barcelona
Publications
- 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. PMID 16247157
- 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. PMID 30851536
- 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. PMID 26252313
- 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. PMID 18830247
- 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. PMID 17518930
- 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
Identifiers
NCT: NCT06395298 · C.I.PIC-108-22