Skip to main content
Clinical Trials/NCT05619224
NCT05619224
Completed
Not Applicable

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

Universidad de Almeria1 site in 1 country56 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Birth
Sponsor
Universidad de Almeria
Enrollment
56
Locations
1
Primary Endpoint
Transition time
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
March 25, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

María del Mar Sánchez Joya

Associate Professor

Universidad de Almeria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Weight(Two years)
  • OFEATINg (Oral FEeding Assessment in premaTure Infants)(Two years)
  • Head circumference.(Two years)
  • PERI(Two years)
  • Neuromotor Development(Two years)
  • Feeding evolution(Two years)
  • Height(Two years)
  • Gross Motor Skills(Two years.)

Study Sites (1)

Loading locations...

Similar Trials