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

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ClinicalTrials.gov Identifier: NCT03036787
Recruitment Status : Withdrawn
First Posted : January 30, 2017
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Muserrefe Nur Keles, Gazi University

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.

Condition or disease Intervention/treatment
Premature Baby Behavioral: family based intervention

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Is There Any Differences in Motor And Cognitive Development Between Preterm (<37 Weeks) and Early Preterm (<32 Weeks) Infants? Two Years Follow Up Study
Actual Study Start Date : February 9, 2014
Actual Primary Completion Date : February 2, 2017
Actual Study Completion Date : September 27, 2018

Group/Cohort Intervention/treatment
moderate-early preterm infants
infant who births in 32 weeks to 37 weeks with family based intervention
Behavioral: family based intervention
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
Behavioral: family based intervention
behavioural advises to family for normal motor development




Primary Outcome Measures :
  1. Motor development assessed with the Alberta Infant Motor Scale [ Time Frame: Each 3 months from beginning to two years ]
    The Alberta Infant Motor Scale is going to use


Secondary Outcome Measures :
  1. Cognitive development assessed with the Bayley Scales of Infant and Toddler Development [ Time Frame: Each 3 months from beginning to two years ]
    Bayley Scales of Infant and Toddler Development



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
preterm infants born with <37 weeks.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036787


Locations
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Turkey
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Ankara, Turkey, 06500
Sponsors and Collaborators
Gazi University
Investigators
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Study Chair: Bulent Elbasan, Phd Gazi University

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Responsible Party: Muserrefe Nur Keles, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT03036787     History of Changes
Other Study ID Numbers: 11223
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have no decided yet

Keywords provided by Muserrefe Nur Keles, Gazi University:
Premature Baby
motor development
cognitive development

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications