Efficacy of Supporting SAFE Early Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Physiotherapy; Infant Development; Early Intervention
• Intervention / Treatment: Behavioral: SAFE Early İntervention; Behavioral: NDT based therapy

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey
    • Erzurum Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAFE Early Intervention Group; A sensory-based, activity-focused early intervention program was implemented in an enriched environment (SAFE Early intervention). Children in the intervention group received home visits once a month and their families were coached. Families were informed about how to support their children. Home visits were made once a month for 10 weeks.	Behavioral: SAFE Early İntervention; As part of the intervention, sensory-based intervention was applied in an enriched environment. In the home setting, physiotherapists collaborated with the family to advance the intervention. The intervention was revised by making monthly home visits to infants with a corrected age of 42 weeks.; Behavioral: NDT based therapy; Neuromotor evaluations of the babies were performed in a clinical setting. The rehabilitation program to be implemented was given to the family as a booklet. The programs of the children examined in the clinic every month were revised.
Experimental: Control Group; Home-based NDT program was applied to the control group. The babies in the group were examined in a clinic environment and the families were given booklets to support their children's development.	Behavioral: SAFE Early İntervention; As part of the intervention, sensory-based intervention was applied in an enriched environment. In the home setting, physiotherapists collaborated with the family to advance the intervention. The intervention was revised by making monthly home visits to infants with a corrected age of 42 weeks.; Behavioral: NDT based therapy; Neuromotor evaluations of the babies were performed in a clinical setting. The rehabilitation program to be implemented was given to the family as a booklet. The programs of the children examined in the clinic every month were revised.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test of Infant Motor Profile	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant and Toddler Development, Third Edition,	Bayley Scales of Infant and Toddler Development- III is the most widely used tool for assessment of early development.Bayley-III including Cognitive, Language, and Motor scales . "1" if the child meets the scoring criteria for each item; If the child does not meet the criteria, he receives a score of "0". Raw scores for each subtest are summed (Total Raw Score) and then converted to scale scores, composite scores, percentile ranks and confidence intervals using the tables provided in the manual. These scores are used to determine the child's performance compared to norms from typically developing children their age (in months).	10 weeks
Infant/Toddler Sensory Profile 2	The Infant/Toddler Sensory Profile (ITSP) was developed in response to the need for a standardized assessment of sensory processing for infants and toddlers. The ITSP is a caregiver questionnaire designed to measure in-fant/toddler responses to various sensory stimuli. It has two age bands: birth to6 (0-6) months and 7 to 36 (7-36) months, with 36 and 48 items, respectively. Each itemon the ITSP describes a certain behavior that may occur in daily life, with the fre-quency of such behaviors rated by the caregiver on a five-point Likert scale (1=always, 2=frequently, 3=occasionally, 4=seldom, and 5=never).	10 weeks
Infant/Toddler HOME Inventory	It is used to evaluate children's home environment. It evaluates the home environment of children aged 0-3 under six different subheadings. Parents rate the frequency of the child's behavior on a five-point scale from 1 (almost always) to 5 (almost never). The items in this test are; It evaluates six different areas: general, auditory, visual, tactile, vestibular and oral sensory processing. A higher score indicates that the answer occurs less frequently	10 weeks

Collaborators and Investigators

• Sponsor: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): November 15, 2022

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 14574941-302,08,01-

Drug and device information, study documents

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