Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm

Universidad de Almeria

Status: Completed

Conditions: Neurodevelopment Treatment; Premature Babies; Premature Baby 26 to 32 Weeks; Motor Disorder; Neurodevelopment

Treatments: Other: Ordinary care; Other: Early Intervention; Other: Bobath

Study type: Interventional

Funder types: Other

Identifiers

NCT07254780

BOBprem

Details and patient eligibility

About

INTRODUCTION: This project is presented as a continuation of the one approved in 2019 (Code: UALBIO2019/013). Early Intervention is defined as all interventions, including prevention, carried out with children aged 0-6 years, their families, and their environment, in order to respond to what each child needs to advance in their development as early as possible.

Psychomotor Delay indicates a slow developmental trajectory in several areas. Premature infants frequently face a potential psychomotor delay, usually due to the immaturity associated with being born earlier than expected. Children born preterm account for 50% of functional diversity in the pediatric population, presenting sequelae in the perinatal period, in the short term, and in the long term. In a previous study conducted by our group, the importance of early follow-up and treatment for children born very preterm was demonstrated.

Neurodevelopmental disorders with motor impairments in children require physiotherapy treatment from the time of diagnosis, throughout early childhood intervention, and across the lifespan. The most prevalent condition is cerebral palsy, which is the leading cause of childhood disability. Its prevalence ranges from 1.5 to 3.0 per 1,000 live births, with no major changes observed in adolescent and adult populations, and with higher occurrence in males than females. Other important conditions due to their frequency and symptoms include congenital malformations and syndromes.

OBJECTIVE: To analyze the effects of advanced physiotherapy programs on development, activity, and participation in children receiving early intervention and presenting motor disorders.

METHODOLOGY: Clinical trial with experimental groups and one control group. Advanced physiotherapy programs based on evidence will be studied, carried out with and involving the family, and supported by specialized care.

The sample will be obtained from centers and associations collaborating with the University of Almería. Before conducting the study, informed consent will be requested from parents or legal guardians. Baseline assessments and follow-up measurements will be performed. Validated and relevant variables related to development and motor difficulties will be used. The data obtained during the project will be stored in a database.

Enrollment: 60 patients

Sex: All

Ages: 24 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premature infants with a gestational age between 24 and 32 weeks, with an adequate weight for their gestational age

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

TreatBOB

Experimental group

Treatment:

Other: Bobath

TreatNO-BOB

Experimental group

Treatment:

Other: Early Intervention

NoTreat-NO-BOB

Experimental group

Treatment:

Other: Ordinary care