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Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants

NCT05261503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-06-07

No results posted yet for this study

Summary

The aim of this study is to investigate the effectiveness the HEP (Homeostasis-Enrichment-Plasticity) approach, which based upon the principles of enriched environment (EE) and ecological theories of development on preterm infants with developmental delay risk.

Thirty-two preterm infants aged 4-10 months will be randomly divided into 2 groups as the HEP intervention group and the Traditional Physical Therapy (TPT) group.

EE-based intervention will be applied to the HEP intervention group, and traditional physiotherapy will be applied to the TPT group for 12 weeks (24 sessions).

The demographic information of the participants will be recorded. The motor and sensory functions of the infants will be evaluated with, the Peabody Developmental Motor Scales (PDMS-2) and the Test of Sensory Functions in Infants™ (TSFI™), respectively. Additionally, the anxiety status of the parents will be evaluated with the Beck Anxiety Inventory (BAI). All evaluations will be done twice, at the end and at the beginning of 12 weeks.

Conditions

  • Preterm
  • Motor
  • Development, Infant
  • Therapy

Interventions

OTHER

HEP

The Homeostasis-Enrichment-Plasticity (HEP) intervention group will receive 45 minutes of face-to-face environmental enrichment-based intervention one day per week and online home support once a week for 12 weeks.

OTHER

Traditional Phsical Therapy

The Traditional Physical Therapy group will receive a 45-minute intervention, two days a week for 12 weeks.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Principal Investigators

  • Aymen Balıkçı, Asst. Prof. · Fenerbahce University

  • Gamze Çağla Sırma · Istanbul University - Cerrahpasa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-05-01
Completion
2023-05-05

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 NCT05261503 on ClinicalTrials.gov