Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395298
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-01-09
Brief Title:
Effects of the Application of PIOMI in the Oral Feeding of Premature
Sponsor:
Fundació Sant Joan de Déu
Organization:
Fundació Sant Joan de Déu
Study Overview
Official Title:
Effects of the Application of PIOMI Premature Oral Motor Intervention in the Oral Feeding of the Premature Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIOMI
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 patients 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 1040 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 skillsThe 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 n35 preterm infants of gestational age 29-306
The control group will follow the NIDCAP care model and the experimental group will apply the PIOMINIDCAP 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
The incidence of oropharyngeal dysphagia in paediatrics is estimated at 1040 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 skillsThe 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 n35 preterm infants of gestational age 29-306
The control group will follow the NIDCAP care model and the experimental group will apply the PIOMINIDCAP 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None