Clinical trial NCT03146351: The Effects of Family Centered Intervention Program on Preterm Infants
Official title: The Effects of Family Centered Physiotherapy Program on Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Keywords: preterm
infant
physiotherapy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomised clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Motor performance using the Alberta Infant Motor Scale
timeFrame: This study is planned to be completed within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu
Study officials:
References:
citation: Kyno NM, Ravn IH, Lindemann R, Fagerland MW, Smeby NA, Torgersen AM. Effect of an early intervention programme on development of moderate and late preterm infants at 36 months: a randomized controlled study. Infant Behav Dev. 2012 Dec;35(4):916-26. doi: 10.1016/j.infbeh.2012.09.004. Epub 2012 Oct 11.