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

Premature Baby Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03036787
• Other study ID #: 11223
• Status: Withdrawn
• Start date: February 9, 2014
• Est. completion date: September 27, 2018

Study information

• Verified date: September 2018
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 27, 2018
• Est. primary completion date: February 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Premature Baby

Intervention

Behavioral:
• family based intervention
behavioural advises to family for normal motor development

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor development assessed with the Alberta Infant Motor Scale	The Alberta Infant Motor Scale is going to use	Each 3 months from beginning to two years
Secondary	Cognitive development assessed with the Bayley Scales of Infant and Toddler Development	Bayley Scales of Infant and Toddler Development	Each 3 months from beginning to two years