Physiotherapy to Improve Feeding Skills in Preterm Infants

Not Applicable

• Conditions: Parenteral Nutrition; Premature Birth; Motor Disorders; Sucking Behavior; Neurodevelopmental Disorders
• Interventions: Other: Neurodevelopmental stimulation + Oral stimulation; Other: Oral stimulation

• Registration Number: NCT05619224
• Lead Sponsor: Universidad de Almeria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GEO+N	Neurodevelopmental stimulation + Oral stimulation	Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
GEO	Oral stimulation	Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
GEO+N	Oral stimulation	Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Weight	Two years	With a scale in grames
OFEATINg (Oral FEeding Assessment in premaTure Infants)	Two years	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.
Head circumference.	Two years	With a measuring tape in millimeters.
PERI	Two years	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)
Neuromotor Development	Two years	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).
Feeding evolution	Two years	Total oral amount
Height	Two years	With a measuring tape in millimeters.
Gross Motor Skills	Two years.	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).

Trial Locations

Locations (1)

University Hospital Torrecardenas; 🇪🇸 Almería, Spain