Efficacy of Supporting SAFE Early Intervention in the First Months of Life in Infants at Risk: A Randomized Controlled Trial

Gazi University1 site in 1 country26 target enrollmentJanuary 15, 2021

ConditionsInfant Development Physiotherapy Early Intervention

Overview

Phase: N/A
Intervention: Not specified
Conditions: Infant Development
Sponsor: Gazi University
Enrollment: 26
Locations: 1
Primary Endpoint: Test of Infant Motor Profile
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.

Registry

clinicaltrials.gov

Start Date

January 15, 2021

End Date

November 15, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gazi University

Responsible Party

Principal Investigator

Ayse Simsek

Gazi University

Eligibility Criteria

Inclusion Criteria

•Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),
•Having a NICU history of 15 days or more,

Exclusion Criteria

•congenital malformations, metabolic and genetic disease musculoskeletal system anomaly

Outcomes

Primary Outcomes

Test of Infant Motor Profile

Time Frame: 10 weeks

High numerical scores indicate that infants notice and respond to stimuli less than their peers, meaning the infant is hypersensitive, while low numerical scores indicate that infants notice and respond to stimuli more than their peers, or are hypersensitive.