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Efficacy of Supporting SAFE Early Intervention

NCT06361134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

  • Infant Development
  • Physiotherapy
  • Early Intervention

Interventions

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-05-15
Completion
2022-11-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06361134 on ClinicalTrials.gov