Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?

NCT ID: NCT03036787

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-09

Study Completion Date

2018-09-27

Brief Summary

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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.

Detailed Description

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A convenience of infants with premature birth recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Babies divide into two groups according to the gestational ages. Babies with gestational ages between 32-36 weeks and 6 days (including the given days) are categorized as moderate-late preterm, while those born before 32 weeks are grouped as extremely and very preterm. Each group contains 20 babies. First, sociodemographic information and histories of babies are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking.The Alberta Infant Motor Scale is using to evaluate spontaneous motor movements of the baby. It evaluates the baby at prone, supine, sitting, and standing positions. Bayley Scales of Infant and Toddler Development scales screen for cognitive, language, and motor development in babies. All infants will be testing in 3-6-9-12-15-18-24 months of ages.

Conditions

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Premature Baby

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Study Groups

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moderate-early preterm infants

infant who births in 32 weeks to 37 weeks with family based intervention

family based intervention

Intervention Type BEHAVIORAL

behavioural advises to family for normal motor development

extremely-very preterm infants

infant who births in 27 weeks to 32 weeks with family based intervention

family based intervention

Intervention Type BEHAVIORAL

behavioural advises to family for normal motor development

Interventions

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family based intervention

behavioural advises to family for normal motor development

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* age greater than 24 months and born with a gestational age of 37 weeks or more
* having major risk factor
Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Muserrefe Nur Keles

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bulent Elbasan, Phd

Role: STUDY_CHAIR

Gazi University

Locations

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Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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11223

Identifier Type: -

Identifier Source: org_study_id

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