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CompletedNCT05087511Updated Oct 21, 2021

The Effect Of Risk Factors Considered Together With Preterm Birth History on Development

An observational study in Preterm Birth, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 24 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
48
Ages
24 Months to 60 Months
Sex
All
01

Study 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 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.

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Conditions studied

  • Preterm Birth

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Keywords

  • Preterm
  • Risk factors
  • Sensory development
  • Motor development,
  • Pre-school
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 48 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
24 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Born before 37 weeks
  2. Not having a neurological diagnosis
  3. To be 24-60 months old,
  4. To be at a mental level to be able to understand and apply commands

Exclusion criteria

Exclusion Criteria:

  1. Patients with diagnosed neurological, neuromuscular, genetic disease
  2. Children whose parents were not willing to participate in the study were not included in the study.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
48 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

    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

    Other: motor and sensory development assessment

Interventions

  • Othermotor and sensory development assessment

    Peabody Motor Development Scale 2 was used to evaluate motor development and Dunn's Sensory Profile was used to evaluate sensory processing.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-72 months

  2. 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.

    Time frame: 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.

    Time frame: 7-36 month

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Study locations

1 site
  • Gazi University
    Ankara, Yenimahalle, Turkey
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References and documents

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 31141828 ↗
  • Crump 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 21934056 ↗
  • Blair 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 33012568 ↗
  • Vohr 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 10835060 ↗
  • Arpino 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05087511
Lead sponsor
Gazi University
Responsible party
Rabia Eraslan (principal investigator, Gazi University) — Principal investigator
First posted
Oct 21, 2021
Start date
Oct 1, 2020
Primary completion
Jun 30, 2021
Completion
Aug 31, 2021
Last update
Oct 21, 2021

Study contacts

rabia eraslan
principal investigator · Gazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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