Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Time to remove the external feeding device
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- 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.
入排标准
- 年龄范围
- 29 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Time to remove the external feeding device
时间窗: 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
次要结局
- Deferred breastfeeding patients after hospital discharge(Number of patients who are Deferred breast-feeding after hospital discharge ,up to 12 weeks)
- Weight ten days at hospital discharge(Assess weight ten days at 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)
- Weight at hospital discharge(Assess weight discharge day, up to 12 weeks)
- 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)