Physiotherapy to Improve Feeding Skills in Preterm Infants

March 25, 2025 updated by: María del Mar Sánchez Joya, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04009
        • University Hospital Torrecardenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GEO+N
Neurodevelopmental stimulation intervention programme combined with an oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Other: Neurodevelopmental stimulation + Oral stimulation

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.

Other: Oral stimulation
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.
Experimental: GEO
Oral stimulation programme. They recives 10 sesions of 15 minutes of stimulation.
Other: Oral stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transition time
Time Frame: Two years
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
Time Frame: Two years
Total oral amount
Two years
OFEATINg (Oral FEeding Assessment in premaTure Infants)
Time Frame: 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.
Two years
Weight
Time Frame: Two years
With a scale in grames
Two years
Height
Time Frame: Two years
With a measuring tape in millimeters.
Two years
Head circumference.
Time Frame: Two years
With a measuring tape in millimeters.
Two years
PERI
Time Frame: 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)
Two years
Gross Motor Skills
Time Frame: 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).
Two years.
Neuromotor Development
Time Frame: Two years

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
Time Frame: 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).
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

October 22, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FiPrem

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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