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The Effects of Family Centered Intervention Program on Preterm Infants

Primary Purpose

Infant, Premature

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Family based early intervention program (NDT-Bobath based)
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Premature focused on measuring preterm, infant, physiotherapy

Eligibility Criteria

1 Day - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early and moderate preterm group

Late preterm group

Arm Description

Infants born before 34 weeks included in this group

Infants born between 34 and 37 weeks included in this group

Outcomes

Primary Outcome Measures

Motor performance using the Alberta Infant Motor Scale
Alberta Infant Motor Scale is used to examine motor performance.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2017
Last Updated
May 8, 2017
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT03146351
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature
Keywords
preterm, infant, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-randomised clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early and moderate preterm group
Arm Type
Experimental
Arm Description
Infants born before 34 weeks included in this group
Arm Title
Late preterm group
Arm Type
Experimental
Arm Description
Infants born between 34 and 37 weeks included in this group
Intervention Type
Other
Intervention Name(s)
Family based early intervention program (NDT-Bobath based)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor performance using the Alberta Infant Motor Scale
Description
Alberta Infant Motor Scale is used to examine motor performance.
Time Frame
This study is planned to be completed within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have no decided yet
Citations:
PubMed Identifier
23063851
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.
Results Reference
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The Effects of Family Centered Intervention Program on Preterm Infants

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