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Clinical Trials/NCT03146351
NCT03146351
Completed
N/A

The Effects of Family Centered Physiotherapy Program on Preterm Infants

Gazi University1 site in 1 country52 target enrollmentSeptember 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Infant, Premature
Sponsor
Gazi University
Enrollment
52
Locations
1
Primary Endpoint
Motor performance using the Alberta Infant Motor Scale
Status
Completed
Last Updated
8 years ago

Overview

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 moderate and early preterm (<34 weeks) and late preterm (>34 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 effect of early intervention program motor performance in subgroups of preterm infants. Hence the aim of this study is to evaluate the differences in effects of early intervention program on motor development in early and moderate (<34 weeks) and late preterm infants.

Detailed Description

Fifty-two preterm infants corrected age less than 6 months included in this study. They were separated by their birth weeks. Babies with gestational ages between 34-36 weeks and 6 days (including the given days) are categorized as late preterm, while those born before 34 weeks are grouped as moderate and early preterm. Each group contains 26 infants. 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. After the detailed examination, intervention program set up for infants. Both groups receive 3 months family based intervention program. After the intervention program, both groups re-examined.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
July 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Murat Fatih KOCYIGIT

Research Assistant

Gazi University

Eligibility Criteria

Inclusion Criteria

  • Born before 37 gestational weeks,
  • Accepting to join the study
  • Corrected age 6 months or less

Exclusion Criteria

  • Having high risk factors (e.g. grade 3 or more intraventricular hemorrhage, PVL, serious seizure)
  • Born after 37 weeks
  • Corrected age greater than 6 months

Outcomes

Primary Outcomes

Motor performance using the Alberta Infant Motor Scale

Time Frame: This study is planned to be completed within 6 months

Alberta Infant Motor Scale is used to examine motor performance.

Study Sites (1)

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