Preterm InfantNCT03313427
Early Physical Therapy Intervention in Preterm Infants
A study testing Physical Therapy Early Intervention in people with Preterm Infant and Physical Therapy, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age). Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Physical Therapy, Early Intervention
- What is being tested?
- Physical Therapy Early Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2017to 1 Dec 2019
- 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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants, gestational age between 28-34 weeks
- Families with ability to take care of the child, without chronic or mental illness
- Long-term parental presence in the hospital (at least 10h/day)
Who cannot join
- Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
- Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
- Children with musculoskeletal deformities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).
There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.
Read more
The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.
The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.
- Conditions
- Preterm Infant, Physical Therapy, Early Intervention, NICU, Home, Motor Development
- Being tested
- Physical Therapy Early Intervention, Usual Care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy Early InterventionOther
At the UCIN:
- Parental education to empower them on motor development and parent-infant relationship. Consisted on 6 sessions during the first weeks at the NICU.
- Tactile and kinaesthetic stimulation managed by parents. 2 times a day, 15 minutes each, during 10 days.
At home:
Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age.
Usual CareOther
NICU usual care
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Usual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model. Receives: Other: Physical Therapy Early Intervention |
| Control | Other | Usual care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development.
Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.
Measured: 2 months corrected age and 8 months corrected age
Secondary outcomes (4)
Movement quality.
Assessed by the General Movements Assessment. The assessment provide the quality of the movement (suboptimal/optimal/pathological).
Measured: 40 weeks postmenstrual age and 2 months corrected age
Gross motor and fine motor function.
Assessed by the Bayley Scale of Infant Development III. Percentile ranks from 1 to 99. Higher percentile represent a better outcome
Measured: 8 months corrected age
Development and risk of development delay.
Assessed by the Ages and Stages Questionnaires Third Edition (ASQ-3). 30 questions covering 5 domains of development: communication, gross motor, fine motor, problem-solving and adaptive skills.
Measured: 1 months corrected age and 8 months corrected age
Mothers' stress index.
Assessed by the Parents Stress Index - Short Form. Composed of 36 items with a Likert-type answer format of five options.
Measured: after the intervention, 3 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Responsible party
- Principal investigator, Mirari Ochandorena Acha, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313427
- Sponsor's protocol ID
- PTNEO-001
- Status last verified
- Dec 2019
- First submitted
- 9 Oct 2017
- Last updated
- 9 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ochandorena-Acha M, Terradas-Monllor M, Lopez Sala L, Cazorla Sanchez ME, Fornaguera Marti M, Munoz Perez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children (Basel). 2022 Jun 15;9(6):895. doi: 10.3390/children9060895.
PubMed 35740832
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Physical Therapy Intervention in Preterm Infants During the Stay in the Neonatal Intensive Care Unit and at Home to Promote Motor Development
- ClinicalTrials.gov ID
- NCT03313427
- Acronym / sponsor ID
- PTNEO-001
- Conditions
- Preterm Infant, Physical Therapy, Early Intervention, NICU, Home, Motor Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Hospital Sant Joan de Deu
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 18 Oct 2017 (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.
The hypothesis of this study is that early physical therapy intervention, initiated during the NICU stay and up to 2 months corrected age, based on the family-centered model, could promote preterm infants motor development in short-term (2 months corrected age) and long-term (8 months corrected age).
There is a high evidence level of different systematic reviews, which support the effectivity of early intervention with preterm infants.
The principal aim of this randomized controlled trial is to evaluate the effectiveness of early physiotherapy intervention to promote motor development in preterm infants at 2 and 8 months corrected age.
The secondary purpose is to study the motor development of those preterm infants who received early physical therapy intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physical Therapy Early InterventionUsual care Early physical therapy intervention at the UCIN and after discharge, at home; based on the family-centered model. |
| Control | Other | Other: Usual CareUsual care |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants, gestational age between 28-34 weeks
- Families with ability to take care of the child, without chronic or mental illness
- Long-term parental presence in the hospital (at least 10h/day)
Key exclusion criteria (3 listed)
- Children diagnosed with congenital disease or brain injury (LPV, HIV), before or during the study
- Children undergoing major surgery (cardiac intervention, Ductus, thoracic intervention)
- Children with musculoskeletal deformities
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 |
|---|---|---|
| Physical Therapy Early InterventionAt the UCIN: * Parental education to empower them on motor development and parent-infant relationship. Consisted on 6 sessions during the first weeks at the NICU. * Tactile and kinaesthetic stimulation managed by parents. 2 times a day, 15 minutes each, during 10 days. At home: Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age. | Other | Intervention |
| Usual CareNICU usual care | Other | Control |
Primary outcome
Motor development.
Time frame: 2 months corrected age and 8 months corrected age
Assessed by the Alberta Infant Motor Scale (AIMS). Total maximum score 40 points. Higher values represent a better outcome.
4 secondary outcomes
Movement quality.
Time frame: 40 weeks postmenstrual age and 2 months corrected age
Gross motor and fine motor function.
Time frame: 8 months corrected age
Development and risk of development delay.
Time frame: 1 months corrected age and 8 months corrected age
Mothers' stress index.
Time frame: after the intervention, 3 months corrected age
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 9 Dec 2019.
- Derived from this study: PubMed 35740832Ochandorena-Acha M, Terradas-Monllor M, Lopez Sala L, Cazorla Sanchez ME, Fornaguera Marti M, Munoz Perez I, Agut-Quijano T, Iriondo M, Casas-Baroy JC. Early Physiotherapy Intervention Program for Preterm Infants and Parents: A Randomized, Single-Blind Clinical Trial. Children (Basel). 2022 Jun 15;9(6):895. doi: 10.3390/children9060895.
- Individual participant dataSharing planned: No
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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 Physical Therapy Early Intervention in people with Preterm Infant and Physical Therapy, run by University of Vic - Central University of Catalonia 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 3 inclusion and 3 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 9 Dec 2019. 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?
Motor development. (time frame: 2 months corrected age and 8 months corrected age). 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 NCT03313427, which also lists 1 linked publication.
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 9 Dec 2019.