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

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087511
• Other study ID #: Development in preterm birth
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: October 2021
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 60 Months

Eligibility

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:

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Other:
• motor 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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Vollmer B, Stålnacke 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-72 months
Primary	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.	3-10 years
Secondary	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.	7-36 month