Disorder; Feeding, Newborn, Dysphagia, Premature
Conditions
Keywords
Swallowing, Swallowing disorders, Nutritional support, Feeding disorders, Preterm, Neonates, Sucking Behavior
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.
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
OTHERExperimental 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
OTHERControl 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)
Sponsors
Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Nexe Foundation
University Ramon Llull
Borja Institute of Bioethics
Institut de Recerca Sant Joan de Déu
Fundació Sant Joan de Déu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
* 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.
Intervention model description
* 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)
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 30 Weeks
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to remove the external feeding device | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization days | Days that the premature baby remains hospitalized from birth to hospital discharge up to 12 weeks | Quantify the days from birth to hospital discharge. |
| Breastfeeding patients after hospital discharge | 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. |
| Deferred breastfeeding patients after hospital discharge | 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 |
| Formula feeding patients after hospital discharge | 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. |
| Volume of intake at discharge | 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. |
| Weight ten days at hospital discharge | Assess weight ten days at hospital discharge, up to 12 weeks | Differences between discharge and 10-day weights |
| Weight at hospital discharge | Assess weight discharge day, up to 12 weeks | To estimate the existence of significant differences between the group that presented intervention and the control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Results of the items of the evaluation Early Feeding Skills (EFS) | 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. |
| 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) | 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. |
Countries
Spain
Contacts
Primary ContactRaquel García Equerra
Backup ContactVanesa Ejarque Marin
Outcome results
None listed