- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036787
Is There Any Differences in Motor and Cognitive Development Between Preterm and Early Preterm Infants?
September 27, 2018 updated by: Muserrefe Nur Keles, Gazi University
Is There Any Differences in Motor And Cognitive Development Between Preterm (<37 Weeks) and Early Preterm (<32 Weeks) Infants? Two Years Follow Up Study
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06500
- Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
preterm infants born with <37 weeks.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
moderate-early preterm infants
infant who births in 32 weeks to 37 weeks with 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
|
behavioural advises to family for normal motor development
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Each 3 months from beginning to two years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Each 3 months from beginning to two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2014
Primary Completion (Actual)
February 2, 2017
Study Completion (Actual)
September 27, 2018
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
January 27, 2017
First Posted (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Actual)
September 28, 2018
Last Update Submitted That Met QC Criteria
September 27, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11223 (FUNDESALUD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
We have no decided yet
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature Baby
-
ElsanClinique BouchardNot yet recruitingPremature Baby 26 to 32 Weeks | Premature Baby 33 to 36 Weeks | Premature - Weight 1000g-2499g or Gestation of 28-37weeks | Premature Between 32 and 36 Weeks of AmenorrhoeaFrance
-
University Hospital, BordeauxRecruitingPremature Baby 26 to 32 Weeks | Premature Baby 33 to 36 WeeksFrance
-
Chinese University of Hong KongCompletedVery Premature Baby
-
Nurgül TekinNot yet recruitingPain | Aspiration | Premature Baby 26 to 32 Weeks | Premature Baby 33 to 36 Weeks
-
Queen's University, BelfastPublic Health Agency, Health and Social Care Research and Development; Tiny...Completed
-
Centre Hospitalier Universitaire, AmiensRecruitingPremature Infant | Mother-Baby SynchronyFrance
-
Université de MontréalCompletedPremature Baby 26 to 32 WeeksCanada
-
University of PatrasUniversity Hospital of PatrasEnrolling by invitationPreterm Birth | Premature Baby 26 to 32 WeeksGreece
-
Eskisehir Osmangazi UniversityNot yet recruiting
-
Universidad de AlmeriaCompletedMotor Disorder | Neurodevelopment | Premature Baby 26 to 32 Weeks | Premature Babies | Neurodevelopment TreatmentSpain
Clinical Trials on family based intervention
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Mayo ClinicNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Yuzuncu Yil UniversityActive, not recruitingCoronary Artery Disease | Family SizeTurkey (Türkiye)
-
University of FloridaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Qazvin University Of Medical SciencesUnknownStroke | Medication Adherence | Older AdultsIran, Islamic Republic of
-
Ohio State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
University of California, San FranciscoVisa FoundationCompletedCommunication | Parent-Child RelationsUnited States
-
Boston Children's HospitalCompleted
-
NYU Langone HealthNational Institute of Mental Health (NIMH)Completed
-
The Cleveland ClinicCompletedObesity, ChildhoodUnited States