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

Withdrawn

• Conditions: Premature Baby
• Interventions: Behavioral: family based intervention

• Registration Number: NCT03036787
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-02-09
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Primary Completion: 2017-02-02
• Status Verified: 2018-09
• Study Completion: 2018-09-27
• Last Update Submitted: 2018-09-27
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
extremely-very preterm infants	family based intervention	infant who births in 27 weeks to 32 weeks with family based intervention
moderate-early preterm infants	family based intervention	infant who births in 32 weeks to 37 weeks with family based intervention

Primary Outcome Measures

Name	Time	Method
Motor development assessed with the Alberta Infant Motor Scale	Each 3 months from beginning to two years	The Alberta Infant Motor Scale is going to use

Secondary Outcome Measures

Name	Time	Method
Cognitive development assessed with the Bayley Scales of Infant and Toddler Development	Each 3 months from beginning to two years	Bayley Scales of Infant and Toddler Development

Trial Locations

Locations (1)

Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation; 🇹🇷 Ankara, Turkey