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

April 29, 2024 updated by: Fundació Sant Joan de Déu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08096
        • Recruiting
        • Raquel García Ezquerra
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raquel García Ezquerra
        • Sub-Investigator:
          • Vanesa Ejarque Marin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Names:
  • PIOMI+NIDCAP
Sham Comparator: 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.
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)
Other Names:
  • NIDCAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume of intake at discharge
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.
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
Quantify the days from birth to hospital discharge.
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
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
Deferred breastfeeding patients after hospital 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
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
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
Weight at hospital 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.
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
Differences between discharge and 10-day weights
Assess weight ten days at hospital discharge, up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results of the items of the evaluation Neonatal Oral-Motor Assessment Scale (NOMAS)
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:

  • 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)
Results of the items of the evaluation Early Feeding Skills (EFS)
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.
The researchers will administer (EFS)last day of intervention (10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Sant Joan de Déu

Collaborators

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

Investigators

  • Principal Investigator: Raquel García Ezquerra, Sant Joan de Déu Hospital
  • Principal Investigator: Vanesa Ejarque Marin, Sant Joan de Déu Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.I.PIC-108-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Initially, the researchers plan to share the study protocol, the statistical analysis and the summary of results obtained, both in congresses and in publications, if applicable.

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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