The Effects of Family Centered Intervention Program on Preterm Infants

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Other: Family based early intervention program (NDT-Bobath based)

• Registration Number: NCT03146351
• 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 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.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Study First Submitted: 2017-04-19
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-09
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late preterm group	Family based early intervention program (NDT-Bobath based)	Infants born between 34 and 37 weeks included in this group
Early and moderate preterm group	Family based early intervention program (NDT-Bobath based)	Infants born before 34 weeks included in this group

Primary Outcome Measures

Name	Time	Method
Motor performance using the Alberta Infant Motor Scale	This study is planned to be completed within 6 months	Alberta Infant Motor Scale is used to examine motor performance.

Trial Locations

Locations (1)

Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu; 🇹🇷 Ankara, Turkey