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Completed

NCT Number: NCT05087511

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 month–60 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University

Ankara, Yenimahalle, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

motor and sensory development assessment

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Sensory development

    Time frame: 7-36 month

    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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

The Effect Of Risk Factors Considered Together With Preterm Birth History On Sensory and Motor Development in Preschool Children

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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