Premature Baby 26 to 32 WeeksNCT07254780
Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm
A study testing Bobath, Early Intervention and Ordinary care in people with Premature Baby 26 to 32 Weeks and Premature Babies, run by Universidad de Almeria at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 24 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Baby 26 to 32 Weeks, Premature Babies, Neurodevelopment Treatment
- What is being tested?
- Bobath, Early Intervention and Ordinary care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2023to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature infants with a gestational age between 24 and 32 weeks, with an adequate weight for their gestational age
Who cannot join
- Neurological disorders
- Invasive mechanical ventilation
- Congenital disorders
- Necrotising enterocolitis
- Metabolic diseases
- Intraventricular hemorrhage grade 3-4
Show all 9Show fewer
- Genetic disorders
- Oral disorders that make this process difficult(cleft palate, cleft lip...)
- Serious illnesses according to medical criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Premature Baby 26 to 32 Weeks, Premature Babies, Neurodevelopment Treatment, Neurodevelopment, Motor Disorder
- Being tested
- Bobath, Early Intervention, Ordinary care
- Keywords
- Physical Stimulation, Premature infant, Neurodevelopment, Neurodevelopment Treatment
- Medical subject headings
- Premature Birth, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BobathOther
This group will receive an intervention based on the Bobath Concept, following the Bobath Clinical Reasoning Framework (BCRF). This approach adopts a holistic, systems-science perspective, considering the dynamic interaction between body functions, activities, participation, and contextual factors according to the ICF model.
Early InterventionOther
This group will receive standard pediatric physiotherapy commonly implemented in early intervention services for children with motor disorders. The treatment will follow conventional approaches with a more impairment-based focus
Ordinary careOther
This group will receive ordinary care, defined as the standard protocol-based follow-up provided by the public health system, unrelated to Early Intervention physiotherapy services
| Study group | Role | What they receive |
|---|---|---|
| TreatBOB | Experimental | Not described Receives: Other: Bobath |
| TreatNO-BOB | Experimental | Not described Receives: Other: Early Intervention |
| NoTreat-NO-BOB | Experimental | Not described Receives: Other: Ordinary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Skills
To evaluate the baby's gross motor competence during early motor development, the investigators will employ the Alberta Infant Motor Scale (AIMS). This tool, developed by Canadian researchers, is an observational assessment designed for infants from birth until they achieve independent walking. It includes 58 items that examine antigravity muscle control and overall motor performance across four positions: prone, supine, sitting, and standing (de Albuquerque et al., 2015).
This tool provides percentile scores (0-100) for gross motor developmental, with higher scores indicating more advanced abilities.
Measured: 2 Years
Neuromotor Development
To evaluate motor, cognitive, and language development, the investigators will use the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), one of the most widely applied instruments for assessing early development. Its primary purpose is to identify children who may present developmental delays and to guide the planning of appropriate interventions. The Bayley-III consists of six subscales that measure cognitive, language, motor, social-emotional, adaptive, and behavioral skills in children aged 1 to 42 months (de Albuquerque et al., 2018).
This tool provides percentile scores (0-100) for each developmental domain, with higher scores indicating more advanced abilities.
Measured: 2 Years
Secondary outcomes (1)
Parents Experiences about Development
To screen overall developmental progress, the investigators will use the Ages \& Stages Questionnaires, Third Edition (ASQ-3). This parent-completed tool assesses children from 1 to 66 months across five domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Each questionnaire includes age-specific items that allow caregivers to report their child's abilities through simple observations.
The ASQ-3 helps identify children who may need monitoring or further evaluation, providing a practical and reliable measure of early developmental functioning.
This tool provides scores (0-60) for each developmental domain, with higher scores indicating more advanced abilities.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start22 Jul 2023
- Primary completion22 Jul 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature Baby 26 to 32 WeeksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Sánchez Joya, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254780
- Sponsor's protocol ID
- BOBprem
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
Bernabe-Zuniga JE, Rodriguez-Lucenilla MI, Alias-Castillo AJ, Rueda-Ruzafa L, Roman P, Del Mar Sanchez-Joya M. Early interventions with parental participation and their implications on the neurodevelopment of premature children: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2025 Mar;34(3):853-865. doi: 10.1007/s00787-024-02528-1. Epub 2024 Jul 19.
PubMed 39028424Alonso-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.
PubMed 35551222de 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.
PubMed 25279804Albuquerque 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.
PubMed 28537470Seesahai 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.
PubMed 34384482
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Treatment Program Based on the Bobath Concept After Hospital Discharge in Children Born Very Preterm
- ClinicalTrials.gov ID
- NCT07254780
- Acronym / sponsor ID
- BOBprem
- Conditions
- Premature Baby 26 to 32 Weeks, Premature Babies, Neurodevelopment Treatment, Neurodevelopment, Motor Disorder
- Keywords
- Physical Stimulation, Premature infant, Neurodevelopment, Neurodevelopment Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TreatBOB | Experimental | Other: Bobath |
| TreatNO-BOB | Experimental | Other: Early Intervention |
| NoTreat-NO-BOB | Experimental | Other: Ordinary care |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature infants with a gestational age between 24 and 32 weeks, with an adequate weight for their gestational age
Key exclusion criteria (9 listed)
- Neurological disorders
- Invasive mechanical ventilation
- Congenital disorders
- Necrotising enterocolitis
- Metabolic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BobathThis group will receive an intervention based on the Bobath Concept, following the Bobath Clinical Reasoning Framework (BCRF). This approach adopts a holistic, systems-science perspective, considering the dynamic interaction between body functions, activities, participation, and contextual factors according to the ICF model. | Other | TreatBOB |
| Early InterventionThis group will receive standard pediatric physiotherapy commonly implemented in early intervention services for children with motor disorders. The treatment will follow conventional approaches with a more impairment-based focus | Other | TreatNO-BOB |
| Ordinary careThis group will receive ordinary care, defined as the standard protocol-based follow-up provided by the public health system, unrelated to Early Intervention physiotherapy services | Other | NoTreat-NO-BOB |
Primary outcome
Gross Motor Skills
Time frame: 2 Years
To evaluate the baby's gross motor competence during early motor development, the investigators will employ the Alberta Infant Motor Scale (AIMS). This tool, developed by Canadian researchers, is an observational assessment designed for infants from birth until they achieve independent walking. It includes 58 items that examine antigravity muscle control and overall motor performance across four positions: prone, supine, sitting, and standing (de Albuquerque et al., 2015). This tool provides percentile scores (0-100) for gross motor developmental, with higher scores indicating more advanced abilities.
Neuromotor Development
Time frame: 2 Years
To evaluate motor, cognitive, and language development, the investigators will use the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), one of the most widely applied instruments for assessing early development. Its primary purpose is to identify children who may present developmental delays and to guide the planning of appropriate interventions. The Bayley-III consists of six subscales that measure cognitive, language, motor, social-emotional, adaptive, and behavioral skills in children aged 1 to 42 months (de Albuquerque et al., 2018). This tool provides percentile scores (0-100) for each developmental domain, with higher scores indicating more advanced abilities.
1 secondary outcome
Parents Experiences about Development
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 39028424Bernabe-Zuniga JE, Rodriguez-Lucenilla MI, Alias-Castillo AJ, Rueda-Ruzafa L, Roman P, Del Mar Sanchez-Joya M. Early interventions with parental participation and their implications on the neurodevelopment of premature children: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2025 Mar;34(3):853-865. doi: 10.1007/s00787-024-02528-1. Epub 2024 Jul 19.
- Background: PubMed 35551222Alonso-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.
- Background: PubMed 25279804de 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.
- Background: PubMed 28537470Albuquerque 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.
- Background: PubMed 34384482Seesahai 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.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath, Early Intervention and Ordinary care in people with Premature Baby 26 to 32 Weeks and Premature Babies, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Skills (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07254780, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.