Clinical trial NCT03036787: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Premature Baby
Keywords: Premature Baby
motor development
cognitive development
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 0
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: preterm infants born with \<37 weeks.

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.

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

Primary outcomes:
measure: Motor development assessed with the Alberta Infant Motor Scale
timeFrame: Each 3 months from beginning to two years
Secondary outcomes:
measure: Cognitive development assessed with the Bayley Scales of Infant and Toddler Development
timeFrame: Each 3 months from beginning to two years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Bulent Elbasan, Phd
role: STUDY_CHAIR
References: