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

NCT06395298 | Recruiting DMC

• 1 other identifier: C.I.PIC-108-22
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Disorder; Feeding, Newborn; Premature

Keywords

Swallowing; Swallowing disorders; Nutritional support; Feeding disorders; Preterm; Neonates; Sucking Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Volume of intake at discharge

  Milliliters that the baby take orally until the day of hospital discharge up to 4 weeks

• Hospitalization days

  Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks

• Breastfeeding patients after hospital discharge

  Number of patients who are breast-feeding after hospital discharge up to 12 weeks

• Deferred breastfeeding patients after hospital discharge

  Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks

• Formula feeding patients after hospital discharge

  Number of patients who are formula feeding after hospital discharge, up to 12 weeks

Other Outcomes (2)

• Results of the items of the evaluation Neonatal Oral-Motor Assessment Scale (NOMAS)

  The researchers will administer Neonatal Oral-Motor Assessment Scale (NOMAS)last day of intervention(10 days)

• Results of the items of the evaluation Early Feeding Skills (EFS)

  The researchers will administer (EFS)last day of intervention (10 days)

Study Arms (2)

Experimental Group PIOMI

EXPERIMENTAL

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.

Other: Experimental group PIOMI

Control Group NIDCAP

SHAM COMPARATOR

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.

Other: Control group NIDCAP

Interventions

Experimental group PIOMI OTHER

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

Also known as: PIOMI+NIDCAP

Experimental Group PIOMI

Control group NIDCAP OTHER

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)

Also known as: NIDCAP

Control Group NIDCAP

Eligibility Criteria

• Age: 29 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica: collaborator
• Nexe Foundation: collaborator
• University Ramon Llull: collaborator
• Borja Institute of Bioethics: collaborator
• Institut de Recerca Sant Joan de Déu: collaborator

Study Sites (1)

Raquel García Ezquerra

Barcelona, Catalonia, 08096, Spain

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders; Premature Birth; Feeding and Eating Disorders; Sucking Behavior

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Raquel García Ezquerra

  Sant Joan de Déu Hospital

  PRINCIPAL INVESTIGATOR

• Vanesa Ejarque Marin

  Sant Joan de Déu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel García Equerra

CONTACT

639423251; raquel.garciae@sjd.es

Vanesa Ejarque Marin

CONTACT

637797057; vanesa.ejarque@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: * Masking: Double blind * 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Assignment: Random and parallel using the OxMaR (Oxford Minimization and Randomization) software * 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)

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: May 2, 2024
• Study Start: February 13, 2023
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year

Locations

ES (1)