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Physiotherapy to Improve Feeding Skills in Preterm Infants

Primary Purpose

Premature Birth, Parenteral Nutrition, Motor Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neurodevelopmental stimulation + Oral stimulation
Oral stimulation
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Premature Birth, Neurodevelopmental Disorders, NICU, Physical Stimulation

Eligibility Criteria

27 Weeks - 32 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Torrecardenas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GEO+N

GEO

Arm Description

Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.

Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.

Outcomes

Primary Outcome Measures

Transition time
The transition time from tube to oral feeding. To complete this, the baby has to feed independently during two consecutive days.

Secondary Outcome Measures

Feeding evolution
Total oral amount
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.
Weight
With a scale in grames
Height
With a measuring tape in millimeters.
Head circumference.
With a measuring tape in millimeters.
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)
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).
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.
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).

Full Information

First Posted
October 22, 2022
Last Updated
November 8, 2022
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT05619224
Brief Title
Physiotherapy to Improve Feeding Skills in Preterm Infants
Official Title
Efficacy of a Physiotherapy Intervention to Improve Feeding Skills in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Parenteral Nutrition, Motor Disorders, Neurodevelopmental Disorders, Sucking Behavior
Keywords
Premature Birth, Neurodevelopmental Disorders, NICU, Physical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GEO+N
Arm Type
Experimental
Arm Description
Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Arm Title
GEO
Arm Type
Experimental
Arm Description
Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental stimulation + Oral stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Oral stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transition time
Description
The transition time from tube to oral feeding. To complete this, the baby has to feed independently during two consecutive days.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Feeding evolution
Description
Total oral amount
Time Frame
Two years
Title
OFEATINg (Oral FEeding Assessment in premaTure Infants)
Description
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.
Time Frame
Two years
Title
Weight
Description
With a scale in grames
Time Frame
Two years
Title
Height
Description
With a measuring tape in millimeters.
Time Frame
Two years
Title
Head circumference.
Description
With a measuring tape in millimeters.
Time Frame
Two years
Title
PERI
Description
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)
Time Frame
Two years
Title
Gross Motor Skills
Description
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).
Time Frame
Two years.
Title
Neuromotor Development
Description
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.
Time Frame
Two years
Title
Neuromotor Development
Description
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).
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital Torrecardenas
City
Almería
ZIP/Postal Code
04009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
IPD Sharing Time Frame
Data will become available for one year once the study is finished
IPD Sharing Access Criteria
Reasonable request to reproduce the intervention performed on this study
Citations:
PubMed Identifier
1720234
Citation
Scheiner AP, Sexton ME. Prediction of developmental outcome using a perinatal risk inventory. Pediatrics. 1991 Dec;88(6):1135-43.
Results Reference
background
PubMed Identifier
35551222
Citation
Alonso-Fernandez S, de Liria CRG, Lluch-Canut T, Poch-Pla L, Perapoch-Lopez J, Juve-Udina ME, Martinez-Momblan MA, Hurtado-Pardos B, Roldan-Merino JF. Psychometric properties of the oral feeding assessment in premature infants scale. Sci Rep. 2022 May 12;12(1):7836. doi: 10.1038/s41598-022-11521-0.
Results Reference
background
PubMed Identifier
25279804
Citation
de Albuquerque PL, Lemos A, Guerra MQ, Eickmann SH. Accuracy of the Alberta Infant Motor Scale (AIMS) to detect developmental delay of gross motor skills in preterm infants: a systematic review. Dev Neurorehabil. 2015 Feb;18(1):15-21. doi: 10.3109/17518423.2014.955213. Epub 2014 Oct 3.
Results Reference
background
PubMed Identifier
28537470
Citation
Albuquerque PL, Guerra MQF, Lima MC, Eickmann SH. Concurrent validity of the Alberta Infant Motor Scale to detect delayed gross motor development in preterm infants: A comparative study with the Bayley III. Dev Neurorehabil. 2018 Aug;21(6):408-414. doi: 10.1080/17518423.2017.1323974. Epub 2017 May 24.
Results Reference
background
PubMed Identifier
34384482
Citation
Seesahai J, Luther M, Church PT, Maddalena P, Asztalos E, Rotter T, Banihani R. The assessment of general movements in term and late-preterm infants diagnosed with neonatal encephalopathy, as a predictive tool of cerebral palsy by 2 years of age-a scoping review. Syst Rev. 2021 Aug 12;10(1):226. doi: 10.1186/s13643-021-01765-8.
Results Reference
background

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Physiotherapy to Improve Feeding Skills in Preterm Infants

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