The Effects of Family Centered Intervention Program on Preterm Infants

Infant, Premature Clinical Trial

Official title:

The Effects of Family Centered Physiotherapy Program on Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146351
• Other study ID #: MURATKOCYIGIT
• Status: Completed
• Phase: N/A
• First received: April 19, 2017
• Last updated: May 8, 2017
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature

Intervention

Other:
• Family based early intervention program (NDT-Bobath based)
Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home.

Locations

Country	Name	City	State
Turkey	Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kynø 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor performance using the Alberta Infant Motor Scale	Alberta Infant Motor Scale is used to examine motor performance.	This study is planned to be completed within 6 months