Physiotherapy to Improve Feeding Skills in Preterm Infants

Study Overview
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Brief Summary
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INTRODUCTION: Suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. In addition, there are some problems in different systems that get it worse. AIM: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development. METHODOLOGY: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. All preterm infants born between 2022-2023 at University Hospital Torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included. EXPECTED BENEFITS: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. In addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child. RESULTS APPLICABILITY: Improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. It will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.

Official Title
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Efficacy of a Physiotherapy Intervention to Improve Feeding Skills in Preterm Infants

Conditions
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Premature Birth, Parenteral Nutrition, Motor Disorders, Neurodevelopmental Disorders, Sucking Behavior

Intervention / Treatment
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* Other: Neurodevelopmental stimulation + Oral stimulation
* Other: Oral stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature infants with a gestational age between 27 and 32 weeks, with an adequate weight for their gestational age, admitted to the unit of Neonatology, hemodynamically stable and with enteral nutrition Exclusion Criteria: Neurological disorders Invasive mechanical ventilation Congenital disorders Necrotising enterocolitis Metabolic diseases Intraventricular hemorrhage grade 3-4 Genetic disorders Oral disorders that make this process difficult(cleft palate, cleft lip...) Serious illnesses according to medical criteria

Ages Eligible for Study
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Minimum Age: 27 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEO+N<br>Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation. | Other: Neurodevelopmental stimulation + Oral stimulation<br>* Neurodevelopmental intervention seeks to reduce abnormal postures and movement patterns in premature infants, allowing them to experience physiological postures in flexion and receive sensory stimulation. To this is added oral stimulation. These stimulations are performed on alternate days.<br>Other: Oral stimulation<br>* This intervention consists of performing a sensorimotor stimulation of oral structures: stimulating for 7 minutes perioral structures( cheeks, lips and jaw)intraoral structures for 5 minutes and in the last 3 minutes non-nutritive suction stimulation with pacifier or finger.<br>|
| Experimental: GEO<br>Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation. | Other: Oral stimulation<br>* This intervention consists of performing a sensorimotor stimulation of oral structures: stimulating for 7 minutes perioral structures( cheeks, lips and jaw)intraoral structures for 5 minutes and in the last 3 minutes non-nutritive suction stimulation with pacifier or finger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transition time | The transition time from tube to oral feeding. To complete this, the baby has to feed independently during two consecutive days. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding evolution | Total oral amount | Two years | 
| OFEATINg (Oral FEeding Assessment in premaTure Infants) | To assess the ability for oral feeding. This scale was developed in two phases, the first phase being the design and construction of its items, and the second phase consisted of the analysis of the reliability and validity of this scale to through a cross-sectional study conducted in 2016/2017. The Oral FEeding Assessment in premaTure Infants may help clinicians to evaluate oral feeding readiness and oral feeding success, defned as the infant's ability to maintain physiologic stability (Alonso-Fernandez et al., 2022) The total score of the OFEATINg scale is the sum of the scores of all the items, with a minimum score of 13 and a maximum of 52, with a higher score reflecting greater readiness for oral feeding. | Two years | 
| Weight | With a scale in grames | Two years | 
| Height | With a measuring tape in millimeters. | Two years | 
| Head circumference. | With a measuring tape in millimeters. | Two years | 
| PERI | With the hospital discharge report we will be able to carry out the perinatal risk inventory (PERI) obtaining a numerical value that estimates the level of biological risk of the baby. Considering: low risk in scores from 0 to 6, moderate from 7 to 9 and high 10 or more. (Scheiner et al,. 1991) | Two years | 
| Gross Motor Skills | In order to assess the quality of gross motor skills in the motor development of the baby we use the AIMS scale (Alberta Infant Motor Scale). The AIMS is an observational scale created by Canadian researchers to assess the motor development of children from birth to the acquisition of walking. Contains 58 items that assess the integrity and control of the antigravity muscles during different motor skills in prone position, supine position, sitting and standing(de Albuquerque et al, 2015). | Two years. | 
| Neuromotor Development | To know the motor development and cognitive development and language. The Bayley ScaleIII scale is the most used tool to assess development, its main objective is to identify children with a developmental delay and provide information for plan of intervention. It is composed of 6 scales that allow assessing at the level of the cognitive, linguistic, motor, social-emotional, adaptive, and behavior of children between 1 and 42 months (de Albuquerque et al, 2018). With this scale we can determine the percentile the child has in each area of development, with a higher score reflects greater capabilities. | Two years | 
| Neuromotor Development | With the observation and analysis of the General Movements, you can get a lot of information about the situation of the child, allowing prognostic data to be provided to health professionals and family. The main objective of the GM's is to detect early the appearance of abnormal movements and predict possible cerebral palsy (Seesahai et al., 2021). | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, Neurodevelopmental Disorders, NICU, Physical Stimulation