The Effects of Family Centered Intervention Program on Preterm Infants
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedMay 9, 2017
May 1, 2017
8 months
April 19, 2017
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Early and moderate preterm group
EXPERIMENTALInfants born before 34 weeks included in this group
Late preterm group
EXPERIMENTALInfants born between 34 and 37 weeks included in this group
Interventions
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.
Eligibility Criteria
You may qualify if:
- Born before 37 gestational weeks,
- Accepting to join the study
- Corrected age 6 months or less
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gazi Universitylead
Study Sites (1)
Gazi Universitesi, Saglik Bilimleri Fakultesi, Fizyoterapi ve Rehabilitasyon Bolumu
Ankara, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 23063851BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
April 19, 2017
First Posted
May 9, 2017
Study Start
September 1, 2015
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
May 9, 2017
Record last verified: 2017-05