Premature InfantsIMPNCT03188107
Interrater Reliability of Infant Motor Profile
An observational study of Premature Infants and Cerebral Palsy, run by Abant Izzet Baysal University.
Trial summary
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test. Read more about this study
- Who is it for?
- Ages 3 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Infants, Cerebral Palsy, Down Syndrome
- What is being tested?
- Video based assessment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Feb 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 3 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Study population consists of risky infants (premature infants, low birth weighted infants, infants with spina bifida or down syndrome
Who may be able to join
- Clinical Diagnosis of Cerebral Palsy
- Clinical Diagnosis of Down Syndrome
- Clinical Diagnosis of Spina Bifida
Who cannot join
- Uncontrolled Epilepsy
- Severe Congenital Disorders
About this study
Official title: Interrater and Intrarater Reliability of Infant Motor Profile: Assessing Motor Profiles of Risky Infants
The aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
Read the detailed description
It is very hard to assess risky infants because of many problems like lack of cooperation, crying, discomfort ect. But with "Infant Motor Profile (IMP)" it is possible to assess motor behavior of risky infants in their daily environment. The assessment relays on video recordings so after recording the motor behavior many people can score the same children many times to have a certain idea about the infant. With this tool it could be easier to set a therapy program after determining the basic motor problem. In Turkey there are a lot of risky infants which later have diagnosed with Cerebral Palsy, Metabolic Disorders and other diseases. Also there are a lot of infants with Down Syndrome (DS) and Spina Bifida (SB). It has been known motor development is impaired with different childhood conditions but there is less information in literature about motor development of children with SB, DS and other diseases. With this study motor status of risky infants between 3- 24 months old will be explored, interrater and intrarater reliability of Infant Motor Profile will be analyzed.
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders, Spina Bifida, Low; Birthweight, Extremely (999 Grams or Less)
- Being tested
- Video based assessment
- Keywords
- Risky Infant, Cerebral Palsy, Down Syndrome, Spina Bifida, Infant Motor Profile
- Medical subject headings
- Premature Birth, Cerebral Palsy, Down Syndrome, Metabolic Diseases, Spinal Dysraphism, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based assessmentOther
All the infants included in this study will be assessed with Infant Motor Profile based on video recording.
| Study group | Role | What they receive |
|---|---|---|
| Risky Infants | Infants that have risk of developing motor impairment, or infants diagnosed as Spina Bifida, Down Syndrome ect. Receives: Other: Video based assessment | |
| Healthy Infants | Healthy infants that have normal motor development Receives: Other: Video based assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Motor Profile
Video recording based assessment of motor status
Measured: Infants will be assessed at baseline and 3 months later from the first assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startAug 2016
- Primary completionAug 2017
- Study completionFeb 2018 (estimated)
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 Premature InfantsStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Ayse Numanoglu Akbas, Abant Izzet Baysal University
- Investigators
- Ayşe NUMANOĞLU AKBAŞ, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188107
- Sponsor's protocol ID
- AbantIbu01
- Acronym
- IMP
- Status last verified
- Nov 2017
- First submitted
- 13 Jun 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Heineman KR, Bos AF, Hadders-Algra M. Infant Motor Profile and cerebral palsy: promising associations. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:40-5. doi: 10.1111/j.1469-8749.2011.04063.x.
PubMed 21950393
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrater and Intrarater Reliability of Infant Motor Profile: Assessing Motor Profiles of Risky Infants
- ClinicalTrials.gov ID
- NCT03188107
- Acronym / sponsor ID
- IMP / AbantIbu01
- Conditions
- Premature Infants, Cerebral Palsy, Down Syndrome, Metabolic Disorders, Spina Bifida, Low; Birthweight, Extremely (999 Grams or Less)
- Keywords
- Risky Infant, Cerebral Palsy, Down Syndrome, Spina Bifida, Infant Motor Profile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Feb 2018 (estimated)
- First posted
- 15 Jun 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 aim of this study is to assess risky infants (or diagnosed infants) with Infant Motor Profile, and analyze interrater and intrarater reliability of this test.
Detailed description
It is very hard to assess risky infants because of many problems like lack of cooperation, crying, discomfort ect. But with "Infant Motor Profile (IMP)" it is possible to assess motor behavior of risky infants in their daily environment. The assessment relays on video recordings so after recording the motor behavior many people can score the same children many times to have a certain idea about the infant. With this tool it could be easier to set a therapy program after determining the basic motor problem. In Turkey there are a lot of risky infants which later have diagnosed with Cerebral Palsy, Metabolic Disorders and other diseases. Also there are a lot of infants with Down Syndrome (DS) and Spina Bifida (SB). It has been known motor development is impaired with different childhood conditions but there is less information in literature about motor development of children with SB, DS and other diseases. With this study motor status of risky infants between 3- 24 months old will be explored, interrater and intrarater reliability of Infant Motor Profile will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risky Infants | – | Other: Video based assessmentInfants that have risk of developing motor impairment, or infants diagnosed as Spina Bifida, Down Syndrome ect. |
| Healthy Infants | – | Other: Video based assessmentHealthy infants that have normal motor development |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Study population consists of risky infants (premature infants, low birth weighted infants, infants with spina bifida or down syndrome
Key inclusion criteria (3 listed)
- Clinical Diagnosis of Cerebral Palsy
- Clinical Diagnosis of Down Syndrome
- Clinical Diagnosis of Spina Bifida
Key exclusion criteria (2 listed)
- Uncontrolled Epilepsy
- Severe Congenital Disorders
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 |
|---|---|---|
| Video based assessmentAll the infants included in this study will be assessed with Infant Motor Profile based on video recording. | Other | Healthy Infants, Risky Infants |
Primary outcome
Infant Motor Profile
Time frame: Infants will be assessed at baseline and 3 months later from the first assessment.
Video recording based assessment of motor status
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Results publication: PubMed 21950393Heineman KR, Bos AF, Hadders-Algra M. Infant Motor Profile and cerebral palsy: promising associations. Dev Med Child Neurol. 2011 Sep;53 Suppl 4:40-5. doi: 10.1111/j.1469-8749.2011.04063.x.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Infants
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
Ayşe NUMANOĞLU AKBAŞ, PhD principal investigator
Abant Izzet Baysal University
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infants and Cerebral Palsy, run by Abant Izzet Baysal University.
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 2 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Infant Motor Profile (time frame: Infants will be assessed at baseline and 3 months later from the first assessment.). 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 NCT03188107, 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 24 Nov 2017.