PrematureNCT04203589
Explorer Babies Early Intervention Program
A study testing The Explorer Baby Early Intervention Program and Neurodevelopmental Therapy in people with Premature and Developmental Disability, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Premature, Developmental Disability, Cerebral Palsy
- What is being tested?
- The Explorer Baby Early Intervention Program and Neurodevelopmental Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 Apr 2020
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born before than 33 weeks
Who cannot join
- congenital malformations, all levels of asphyxia, intracranial hemorrhage, periventricular leukomalacia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of New Holistic Early Intervention Approach (Explorer Babies): a Randomized Controlled Study
Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. While some early intervention methods can consider body structured findings such as posture, tonus, muscle power, others may consider coaching family, enrichment of the environment. The explorer baby program is developed based on the trial and error process. The program tries to find an answer to a unique question: "how trial behavior in infants can be increased and which behaviors of the infants should be supported to increase their trial process?" The Explorer baby program tries to increase exploratory motor behaviors to facilitate development. For this aim, the program tries to explain how a baby learns new skills such as rolling, sitting, babbling, playing peek a boo, etc. in all domains of development while the baby lives in their natural environment. This study aims to investigate the effect of the explorer baby early intervention program.
Read the detailed description
The aim of the study is to investigate the effect of Explorer Baby Early Intervention Program on explorative motor behaviors, motor, language, and cognitive skills. The study is designed as a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (Explorer Baby) or control group (neurodevelopmental therapy), stratified by birth weeks and educational level of the mother.
There is no developmental support program as standard care in Turkey for premature babies. So that neither intervention nor the control group doesn't take any other support. There will be an average of six intervention sessions during the 6 months intervention period. The assessments will take before intervention (T0), after 3 months after T0 (T1) and after six months after T0 (T2), corrected age one (T3), corrected age two (T4).
Intervention: EXPLORatory motor behavior based Early Intervention Program (Explorer Baby) is a developmental support program for babies and their families. Parents visit the early intervention center with their babies in a variable frequency. The first step of the program is to build up interaction between therapists and parents; worries of parents for the development of their babies, knowledge about child development, knowledge about play behaviors, how babies learn new skills, age-specific requirements of babies, build up interaction with babies and family members, describing blocks for development.
The second step is setting the play in the natural environment working with the family; how do families describe the play? If families want to support the ability of their babies kicking, reaching, rolling, communicate, or social interaction how should they organize the playground? Showing families some examples of enrichment of playground for specific aims.
The third step is observing babies' reactions; how do families motivate their babies for play? How do families encourage their babies for self-starting explorative behaviors? How do parents support making the voice of the baby more if the play context is meaningful for creating a voice? The program doesn't give specific play homework to improve specific skills. The program tries to enrich parents' knowledge about the effect on the behavior of babies in meaningful situations.
The control Group: The control group will take neurodevelopmental therapy. Neurodevelopmental therapy is commonly accepted as traditional therapy.
- Being tested
- The Explorer Baby Early Intervention Program, Neurodevelopmental Therapy
- Keywords
- Premature, Developmental Disability, Motor Disorder, Cerebral Palsy, Early Intervention, developmental Support
- Medical subject headings
- Premature Birth, Developmental Disabilities, Cerebral Palsy, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Explorer Baby Early Intervention ProgramBehavioural
Also called Explorer Baby
Centered based intervention, once or twice a month, 6 months follow up
Neurodevelopmental TherapyOther
Also called Bobath
Centered based intervention, once or twice a month, 6 months follow up
| Study group | Role | What they receive |
|---|---|---|
| The Explorer Early Intervention Program | Experimental | The Explorer Early Intervention Program is used in this group. Receives: Behavioral: The Explorer Baby Early Intervention Program |
| Neurodevelopmental Therapy | Active comparator | Neurodevelopmental therapy is used in these group by two experienced and certificated physiotherapist Receives: Other: Neurodevelopmental Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
The Bayley III is assessing "Cognitive, Receptive Language, Expressive Language, Fine Motor, Gross Motor". Bayley III has a raw score, scale score, composite score, and growth percentile score. All of these scores will be given in the study. But only, the growth percentage score will be discussed as both the subareas and the total score as the primary outcome. Because only the percentage of growth gives the baby's level of development exactly day by day. The percentile score is between 0 and 100. A higher score means improvement is better. The changes in the growth percentage in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the growth percentage scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.
Measured: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Secondary outcomes (3)
Age and Stage Questionnaire 2 (ASQ-2)
The Ages and Stages Questionnaire 2 (ASQ-2) is a widely used screening tool for infants and young children's development assessing development in five domains: Communication, Gross Motor, Fine Motor, Problem Solving and Personal Social. It is is originally a parent-completed questionnaire and it includes six questions for every developmental area. There are three options for the answer "Yes (10 points), Sometimes (5 points), No (0 points)". The raw score is between 0 to 60 points. High points mean better development. The study will use the raw score of all developmental areas. The age range of ASQ-2 is 3 months to 72 months meaning the ASQ-2 will not be used for children younger than 3 months. Post-tests (T1-T2) results will be used for discrimination (according to the parent's view) between children with developmental delays and developing typically in two groups.
Measured: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Parent Stress Index-4-Short Form (PSI SF-4)
The questionnaire is assessing "Parental Distress, Parent-Child Dysfunctional Interaction, Difficult Child" subheadings. High points are mean high-stress behaviour. The raw score is between 36 to 180 points. There are no cut scores in the Turkish version of PSI-4 SF. The changes in the raw scores in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the raw scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.
Measured: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Infant Movement Motivation Questionnaire
The Questionnaire is assessing four subheadings with 27 items: "Activity, exploration, motivation, adaptability". There are no cut scores in these in the Turkish version of the questionnaire. High points mean better development. The raw score is between 27 to 135 points. The changes in the raw scores in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the raw scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.
Measured: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Jun 2018
- Primary completion1 Sep 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Model description
- A parallel randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zubeyir Sari, Marmara University
- Investigators
- Zübeyir Sarı, PhD, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203589
- Sponsor's protocol ID
- 09.2017.729
- Status last verified
- Sep 2020
- First submitted
- 21 Nov 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will share the outcomes of statistics by using tables, figures.
Publications
Babik I, Galloway JC, Lobo MA. Infants Born Preterm Demonstrate Impaired Exploration of Their Bodies and Surfaces Throughout the First 2 Years of Life. Phys Ther. 2017 Sep 1;97(9):915-925. doi: 10.1093/ptj/pzx064.
PubMed 28605484de Campos AC, Savelsbergh GJ, Rocha NA. What do we know about the atypical development of exploratory actions during infancy? Res Dev Disabil. 2012 Nov-Dec;33(6):2228-35. doi: 10.1016/j.ridd.2012.06.016. Epub 2012 Jul 21.
PubMed 22820063Altunalan T, Sari Z, Dogan TD, Hacifazlioglu NE, Akman I, Altintas T, Uzer S, Akcakaya NH. Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. Brain Behav. 2023 Nov;13(11):e3266. doi: 10.1002/brb3.3266. Epub 2023 Oct 5.
PubMed 37798860
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of New Holistic Early Intervention Approach (Explorer Babies): a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04203589
- Acronym / sponsor ID
- 09.2017.729
- Keywords
- Premature, Developmental Disability, Motor Disorder, Cerebral Palsy, Early Intervention, developmental Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 18 Dec 2019 (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.
Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. While some early intervention methods can consider body structured findings such as posture, tonus, muscle power, others may consider coaching family, enrichment of the environment. The explorer baby program is developed based on the trial and error process. The program tries to find an answer to a unique question: "how trial behavior in infants can be increased and which behaviors of the infants should be supported to increase their trial process?" The Explorer baby program tries to increase exploratory motor behaviors to facilitate development. For this aim, the program tries to explain how a baby learns new skills such as rolling, sitting, babbling, playing peek a boo, etc. in all domains of development while the baby lives in their natural environment. This study aims to investigate the effect of the explorer baby early intervention program.
Detailed description
The aim of the study is to investigate the effect of Explorer Baby Early Intervention Program on explorative motor behaviors, motor, language, and cognitive skills. The study is designed as a randomized controlled trial in which infants and their families are randomly assigned to the intervention group (Explorer Baby) or control group (neurodevelopmental therapy), stratified by birth weeks and educational level of the mother.
There is no developmental support program as standard care in Turkey for premature babies. So that neither intervention nor the control group doesn't take any other support. There will be an average of six intervention sessions during the 6 months intervention period. The assessments will take before intervention (T0), after 3 months after T0 (T1) and after six months after T0 (T2), corrected age one (T3), corrected age two (T4).
Intervention: EXPLORatory motor behavior based Early Intervention Program (Explorer Baby) is a developmental support program for babies and their families. Parents visit the early intervention center with their babies in a variable frequency. The first step of the program is to build up interaction between therapists and parents; worries of parents for the development of their babies, knowledge about child development, knowledge about play behaviors, how babies learn new skills, age-specific requirements of babies, build up interaction with babies and family members, describing blocks for development.
The second step is setting the play in the natural environment working with the family; how do families describe the play? If families want to support the ability of their babies kicking, reaching, rolling, communicate, or social interaction how should they organize the playground? Showing families some examples of enrichment of playground for specific aims.
The third step is observing babies' reactions; how do families motivate their babies for play? How do families encourage their babies for self-starting explorative behaviors? How do parents support making the voice of the baby more if the play context is meaningful for creating a voice? The program doesn't give specific play homework to improve specific skills. The program tries to enrich parents' knowledge about the effect on the behavior of babies in meaningful situations.
The control Group: The control group will take neurodevelopmental therapy. Neurodevelopmental therapy is commonly accepted as traditional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| The Explorer Early Intervention Program | Experimental | Behavioral: The Explorer Baby Early Intervention ProgramThe Explorer Early Intervention Program is used in this group. |
| Neurodevelopmental Therapy | Active comparator | Other: Neurodevelopmental TherapyNeurodevelopmental therapy is used in these group by two experienced and certificated physiotherapist |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Born before than 33 weeks
Key exclusion criteria (1 listed)
- congenital malformations, all levels of asphyxia, intracranial hemorrhage, periventricular leukomalacia.
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 |
|---|---|---|
| The Explorer Baby Early Intervention ProgramAlso: Explorer BabyCentered based intervention, once or twice a month, 6 months follow up | Behavioural | The Explorer Early Intervention Program |
| Neurodevelopmental TherapyAlso: BobathCentered based intervention, once or twice a month, 6 months follow up | Other | Neurodevelopmental Therapy |
Primary outcome
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
The Bayley III is assessing "Cognitive, Receptive Language, Expressive Language, Fine Motor, Gross Motor". Bayley III has a raw score, scale score, composite score, and growth percentile score. All of these scores will be given in the study. But only, the growth percentage score will be discussed as both the subareas and the total score as the primary outcome. Because only the percentage of growth gives the baby's level of development exactly day by day. The percentile score is between 0 and 100. A higher score means improvement is better. The changes in the growth percentage in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the growth percentage scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.
3 secondary outcomes
Age and Stage Questionnaire 2 (ASQ-2)
Time frame: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Parent Stress Index-4-Short Form (PSI SF-4)
Time frame: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
Infant Movement Motivation Questionnaire
Time frame: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)
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 4 Sep 2020.
- Background: PubMed 28605484Babik I, Galloway JC, Lobo MA. Infants Born Preterm Demonstrate Impaired Exploration of Their Bodies and Surfaces Throughout the First 2 Years of Life. Phys Ther. 2017 Sep 1;97(9):915-925. doi: 10.1093/ptj/pzx064.
- Background: PubMed 22820063de Campos AC, Savelsbergh GJ, Rocha NA. What do we know about the atypical development of exploratory actions during infancy? Res Dev Disabil. 2012 Nov-Dec;33(6):2228-35. doi: 10.1016/j.ridd.2012.06.016. Epub 2012 Jul 21.
- Derived from this study: PubMed 37798860Altunalan T, Sari Z, Dogan TD, Hacifazlioglu NE, Akman I, Altintas T, Uzer S, Akcakaya NH. Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. Brain Behav. 2023 Nov;13(11):e3266. doi: 10.1002/brb3.3266. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No. The study will share the outcomes of statistics by using tables, figures.
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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.
Zübeyir Sarı, PhD study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Explorer Baby Early Intervention Program and Neurodevelopmental Therapy in people with Premature and Developmental Disability, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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 4 Sep 2020. 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 Turkey (Türkiye). 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?
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) (time frame: This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)). 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 NCT04203589, which also lists 3 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 4 Sep 2020.