The Effects of Family Centered Intervention Program on Preterm Infants

The Effects of Family Centered Physiotherapy Program on Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature
• Intervention / Treatment: Other: Family based early intervention program (NDT-Bobath based)

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early and moderate preterm group; Infants born before 34 weeks included in this group	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.
Experimental: Late preterm group; Infants born between 34 and 37 weeks included in this group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: preterm; physiotherapy; infant
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: MURATKOCYİGİT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We have no decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No