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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date January 27, 2017
First Posted Date January 30, 2017
Last Update Posted Date September 28, 2018
Actual Study Start Date February 9, 2014
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 27, 2017)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?
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
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.
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.
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population preterm infants born with <37 weeks.
Condition Premature Baby
Intervention Behavioral: family based intervention
behavioural advises to family for normal motor development
Study Groups/Cohorts
  • moderate-early preterm infants
    infant who births in 32 weeks to 37 weeks with family based intervention
    Intervention: Behavioral: family based intervention
  • extremely-very preterm infants
    infant who births in 27 weeks to 32 weeks with family based intervention
    Intervention: Behavioral: family based intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: September 27, 2018)
0
Original Estimated Enrollment
 (submitted: January 27, 2017)
40
Actual Study Completion Date September 27, 2018
Actual Primary Completion Date February 2, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 24 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03036787
Other Study ID Numbers 11223
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: We have no decided yet
Responsible Party Muserrefe Nur Keles, Gazi University
Study Sponsor Gazi University
Collaborators Not Provided
Investigators
Study Chair: Bulent Elbasan, Phd Gazi University
PRS Account Gazi University
Verification Date September 2018