Clinical trial NCT05087511: The Effect Of Risk Factors Considered Together With Preterm Birth History on Development
Official title: The Effect Of Risk Factors Considered Together With Preterm Birth History On Sensory and Motor Development in Preschool Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Preterm
Risk factors
Sensory development
Motor development,
Pre-school
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 48
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Motor development
timeFrame: 0-72 months
measure: Sensory development
timeFrame: 3-10 years
Secondary outcomes:
measure: Sensory development
timeFrame: 7-36 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Yenimahalle
Study officials:
affiliation: Gazi University
name: rabia eraslan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. No abstract available.
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. doi: 10.1542/peds.105.6.1216.
citation: 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.