Preterm BirthNCT05087511
The Effect Of Risk Factors Considered Together With Preterm Birth History on Development
An observational study of Preterm Birth, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study. Read more about this study
- Who is it for?
- Ages 24 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- motor and sensory development assessment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 31 Aug 2021
- 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 24 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Only 24 children with a history of preterm birth and 24 children with additional risk factors for preterm birth were included in the study.
Who may be able to join
- Born before 37 weeks
- Not having a neurological diagnosis
- To be 24-60 months old,
- To be at a mental level to be able to understand and apply commands
Who cannot join
- Patients with diagnosed neurological, neuromuscular, genetic disease
- Children whose parents were not willing to participate in the study were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Risk Factors Considered Together With Preterm Birth History On Sensory and Motor Development in Preschool Children
This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study.
Read the detailed description
This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study. Additional risk factors, including respiratory distress syndrome, intraventricular bleeding, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of prematurity, and bronchopulmonary dysplasia, which are common in preterm infants, were recorded. Peabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing.
- Conditions
- Preterm Birth
- Being tested
- motor and sensory development assessment
- Keywords
- Preterm, Risk factors, Sensory development, Motor development,, Pre-school
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor and sensory development assessmentOther
Peabody Motor Development Scale 2 was used to evaluate motor development and Dunn's Sensory Profile was used to evaluate sensory processing.
| Study group | Role | What they receive |
|---|---|---|
| only preterm birth | Peabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing Receives: Other: motor and sensory development assessment | |
| riskly preterm birth | Peabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing Receives: Other: motor and sensory development assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development
Peabody Motor Development Scale-2 was first developed in 1983 by Rhonda Folio and Rebecca Fewell. A second edition was published by the same authors in 2000. Offering separate tests and rating scales for both gross and fine motor skills, it is a frequently preferred tool for assessing the motor development of young children from birth to 72 months. The duration of the test is 45-60 minutes. Gross and fine motor assessments can be done on the same day or at different times. It is important to know the age of the child before starting the assessment and corrected age up to 2 years of age is used in preterm children. Each item is evaluated according to a 3-point (0,1,2) scoring scale. The therapist asks the child to do a certain item and observes how the child does the activity. Items are scored as 2, 1, or 0. Higher scores perform better.
Measured: 0-72 months
Sensory development
The Dunn sensory profile is a questionnaire filled out by a parent or primary caregiver that assesses children's reactions to events and sensory situations they encounter in daily life. The Dunn Sensory profile is suitable for assessing sensory development in children aged 3-10 years. The questionnaire consists of 125 items and the parent evaluates the event defined in each item according to the child's situation. For each of the 125 items, the parent was asked to respond on a five-point Likert scale of 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never. Higher scores perform better.
Measured: 3-10 years
Secondary outcomes (1)
Sensory development
Infant/toddler sensory profile (Dunn sensory profile 7-36) is a parent or caregiver questionnaire that evaluates the responses of children up to 3 years of age to sensory inputs. It was revised and updated as Dunn sensory profile II in 2014. BYDP has forms that evaluate two different age groups, 0-6 months and 7-36 months. It has items in six different sections: general, visual, auditory, vestibular, tactile, and oral. Parents evaluate their child's response to sensory stimuli on a 5-point Likert scale. 'Almost never' five; 'almost always' is rated as one. A higher score indicates that the behavior is observed less frequently. In addition to the total score, the items of the test provide score formation in four quadrants: low registration, sensory sensitivity, sensory avoidance, and sensory seeking.
Measured: 7-36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Oct 2020
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
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 Preterm BirthStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Eraslan, Gazi University
- Investigators
- rabia eraslan, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087511
- Sponsor's protocol ID
- Development in preterm birth
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vollmer B, Stalnacke J. Young Adult Motor, Sensory, and Cognitive Outcomes and Longitudinal Development after Very and Extremely Preterm Birth. Neuropediatrics. 2019 Aug;50(4):219-227. doi: 10.1055/s-0039-1688955. Epub 2019 May 29.
PubMed 31141828Crump C, Sundquist K, Sundquist J, Winkleby MA. Gestational age at birth and mortality in young adulthood. JAMA. 2011 Sep 21;306(11):1233-40. doi: 10.1001/jama.2011.1331.
PubMed 21934056Blair M. Caring for infants after hospital discharge - Are we doing enough? Early Hum Dev. 2020 Nov;150:105192. doi: 10.1016/j.earlhumdev.2020.105192. Epub 2020 Sep 22. No abstract available.
PubMed 33012568Vohr BR, Wright LL, Dusick AM, Mele L, Verter J, Steichen JJ, Simon NP, Wilson DC, Broyles S, Bauer CR, Delaney-Black V, Yolton KA, Fleisher BE, Papile LA, Kaplan MD. Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994. Pediatrics. 2000 Jun;105(6):1216-26. doi: 10.1542/peds.105.6.1216.
PubMed 10835060Arpino C, Compagnone E, Montanaro ML, Cacciatore D, De Luca A, Cerulli A, Di Girolamo S, Curatolo P. Preterm birth and neurodevelopmental outcome: a review. Childs Nerv Syst. 2010 Sep;26(9):1139-49. doi: 10.1007/s00381-010-1125-y. Epub 2010 Mar 27.
PubMed 20349187
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Risk Factors Considered Together With Preterm Birth History On Sensory and Motor Development in Preschool Children
- ClinicalTrials.gov ID
- NCT05087511
- Acronym / sponsor ID
- Development in preterm birth
- Conditions
- Preterm Birth
- Keywords
- Preterm, Risk factors, Sensory development, Motor development,, Pre-school
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 21 Oct 2021 (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.
This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study.
Detailed description
This thesis was planned to examine the effects of risk factors seen with a history of preterm birth on sensory and motor development in preschool children. A total of 48 children, 24 with only a history of preterm birth and 24 with additional risk factors for preterm birth, were included in the study. Additional risk factors, including respiratory distress syndrome, intraventricular bleeding, periventricular leukomalacia, necrotizing enterocolitis, retinopathy of prematurity, and bronchopulmonary dysplasia, which are common in preterm infants, were recorded. Peabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| only preterm birth | – | Other: motor and sensory development assessmentPeabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing |
| riskly preterm birth | – | Other: motor and sensory development assessmentPeabody Motor Development Scale-2 was used to evaluate motor development performances and Dunn Sensory Profile was used to evaluate sensory processing |
Who may qualify
- Ages
- 24 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Only 24 children with a history of preterm birth and 24 children with additional risk factors for preterm birth were included in the study.
Key inclusion criteria (4 listed)
- Born before 37 weeks
- Not having a neurological diagnosis
- To be 24-60 months old,
- To be at a mental level to be able to understand and apply commands
Key exclusion criteria (2 listed)
- Patients with diagnosed neurological, neuromuscular, genetic disease
- Children whose parents were not willing to participate in the study were not included in the study.
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 |
|---|---|---|
| motor and sensory development assessmentPeabody Motor Development Scale 2 was used to evaluate motor development and Dunn's Sensory Profile was used to evaluate sensory processing. | Other | only preterm birth, riskly preterm birth |
Primary outcome
Motor development
Time frame: 0-72 months
Peabody Motor Development Scale-2 was first developed in 1983 by Rhonda Folio and Rebecca Fewell. A second edition was published by the same authors in 2000. Offering separate tests and rating scales for both gross and fine motor skills, it is a frequently preferred tool for assessing the motor development of young children from birth to 72 months. The duration of the test is 45-60 minutes. Gross and fine motor assessments can be done on the same day or at different times. It is important to know the age of the child before starting the assessment and corrected age up to 2 years of age is used in preterm children. Each item is evaluated according to a 3-point (0,1,2) scoring scale. The therapist asks the child to do a certain item and observes how the child does the activity. Items are scored as 2, 1, or 0. Higher scores perform better.
Sensory development
Time frame: 3-10 years
The Dunn sensory profile is a questionnaire filled out by a parent or primary caregiver that assesses children's reactions to events and sensory situations they encounter in daily life. The Dunn Sensory profile is suitable for assessing sensory development in children aged 3-10 years. The questionnaire consists of 125 items and the parent evaluates the event defined in each item according to the child's situation. For each of the 125 items, the parent was asked to respond on a five-point Likert scale of 1 = always, 2 = often, 3 = sometimes, 4 = rarely, and 5 = never. Higher scores perform better.
1 secondary outcome
Sensory development
Time frame: 7-36 month
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 21 Oct 2021.
- Background: PubMed 31141828Vollmer B, Stalnacke J. Young Adult Motor, Sensory, and Cognitive Outcomes and Longitudinal Development after Very and Extremely Preterm Birth. Neuropediatrics. 2019 Aug;50(4):219-227. doi: 10.1055/s-0039-1688955. Epub 2019 May 29.
- Background: PubMed 21934056Crump C, Sundquist K, Sundquist J, Winkleby MA. Gestational age at birth and mortality in young adulthood. JAMA. 2011 Sep 21;306(11):1233-40. doi: 10.1001/jama.2011.1331.
- Background: PubMed 33012568Blair M. Caring for infants after hospital discharge - Are we doing enough? Early Hum Dev. 2020 Nov;150:105192. doi: 10.1016/j.earlhumdev.2020.105192. Epub 2020 Sep 22. No abstract available.
- Background: PubMed 10835060Vohr BR, Wright LL, Dusick AM, Mele L, Verter J, Steichen JJ, Simon NP, Wilson DC, Broyles S, Bauer CR, Delaney-Black V, Yolton KA, Fleisher BE, Papile LA, Kaplan MD. Neurodevelopmental and functional outcomes of extremely low birth weight infants in the National Institute of Child Health and Human Development Neonatal Research Network, 1993-1994. Pediatrics. 2000 Jun;105(6):1216-26. doi: 10.1542/peds.105.6.1216.
- Background: PubMed 20349187Arpino C, Compagnone E, Montanaro ML, Cacciatore D, De Luca A, Cerulli A, Di Girolamo S, Curatolo P. Preterm birth and neurodevelopmental outcome: a review. Childs Nerv Syst. 2010 Sep;26(9):1139-49. doi: 10.1007/s00381-010-1125-y. Epub 2010 Mar 27.
- 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.
rabia eraslan principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Gazi 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 4 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: finished, as of the sponsor's last update on 21 Oct 2021. 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?
Motor development (time frame: 0-72 months). 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 NCT05087511, 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 21 Oct 2021.