Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?
1 other identifier
observational
N/A
1 country
1
Brief Summary
Infant born preterm have an increased risk of adverse long-term developmental outcomes.The risk associated with preterm birth increase as gestational age decreases, and vulnerability remains in extremely- very preterm (\<32 weeks) and moderate- late preterm (\>32 weeks). There are many studies in the literature showed that the prevalence of developmental delay increases with premature birth. However, there is no study in the literature investigates long term follow up motor and cognitive development in subgroups of preterm infants . Hence the aim of this study is to evaluate the differences in motor and cognitive development in moderate-late (\>32 weeks) and extremely-very preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
Longer than P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2014
CompletedFirst Submitted
Initial submission to the registry
January 27, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2018
CompletedSeptember 28, 2018
September 1, 2018
3 years
January 27, 2017
September 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor development assessed with the Alberta Infant Motor Scale
The Alberta Infant Motor Scale is going to use
Each 3 months from beginning to two years
Secondary Outcomes (1)
Cognitive development assessed with the Bayley Scales of Infant and Toddler Development
Each 3 months from beginning to two years
Study Arms (2)
moderate-early preterm infants
infant who births in 32 weeks to 37 weeks with family based intervention
extremely-very preterm infants
infant who births in 27 weeks to 32 weeks with family based intervention
Interventions
behavioural advises to family for normal motor development
Eligibility Criteria
preterm infants born with \<37 weeks.
You may qualify if:
- adjusted age of 24 months or less, born with a gestational age of 36 weeks and 6 days or earlier, not having any systemic disease, and accepting to join the study
You may not qualify if:
- age greater than 24 months and born with a gestational age of 37 weeks or more
- having major risk factor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06500, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bulent Elbasan, Phd
Gazi University
Study Design
- Study Type
- observational
- Observational Model
- FAMILY BASED
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
January 27, 2017
First Posted
January 30, 2017
Study Start
February 9, 2014
Primary Completion
February 2, 2017
Study Completion
September 27, 2018
Last Updated
September 28, 2018
Record last verified: 2018-09