Effects of the Application of PIOMI in the Oral Feeding of Premature

Dysphagia Clinical Trial

— PIOMI  

Official title:

Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06395298
• Other study ID #: C.I.PIC-108-22
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Fundació Sant Joan de Déu
• Contact: Raquel García Equerra
• Phone: 639423251
• Email: raquel.garciae[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 30, 2026
• Est. primary completion date: June 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 30 Weeks

Eligibility

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).

Related Conditions & MeSH terms

• Dysphagia
• Premature
• Premature Birth

Intervention

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
• 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)

Locations

Country	Name	City	State
Spain	Raquel García Ezquerra	Barcelona	Catalonia

Sponsors (6)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Borja Institute of Bioethics, Institut de Recerca Sant Joan de Déu, Nexe Foundation, Spanish Society of Pediatric Gastroenterology, Hepatology and Nutrition, University Ramon Llull

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Results of the items of the evaluation Neonatal Oral-Motor Assessment Scale (NOMAS)	The NOMAS tool consists of 29 items distributed in 3 domains: Normal pattern: The range is from 27 to 40, with 27 being the lowest score and 40 being the highest score.; Disorganized pattern:The range is from 14 to 26, with 14 being the lowest score and 26 being the highest score.; Disfunctional pattern:The range is from 0 to 14, with 0 being the lowest score and 14 being the highest score.; 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.	The researchers will administer Neonatal Oral-Motor Assessment Scale (NOMAS)last day of intervention(10 days)
Other	Results of the items of the evaluation Early Feeding Skills (EFS)	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.	The researchers will administer (EFS)last day of intervention (10 days)
Primary	Time to remove the external feeding device	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	Days of life of the baby when the external feeding device is removed assessed up to 30 days
Secondary	Volume of intake at discharge	To perform a proper calculation, the investigator must quantify the volumen of milk in millilitres from the day of device removal until hospital discharge.	Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks
Secondary	Hospitalization days	Quantify the days from birth to hospital discharge.	Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks
Secondary	Breastfeeding patients after hospital discharge	Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.	Number of patients who are breast-feeding after hospital discharge up to 12 weeks
Secondary	Deferred breastfeeding patients after hospital discharge	Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge	Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks
Secondary	Formula feeding patients after hospital discharge	Quantify the babies who perform Breastfeeding, Deferred breastfeeding or Artificial Breastfeeding according to the group assigned at discharge.	Number of patients who are formula feeding after hospital discharge, up to 12 weeks
Secondary	Weight at hospital discharge	To estimate the existence of significant differences between the group that presented intervention and the control.	Assess weight discharge day, up to 12 weeks
Secondary	Weight ten days at hospital discharge	Differences between discharge and 10-day weights	Assess weight ten days at hospital discharge, up to 12 weeks