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

NCT05261503 | Completed

• 1 other identifier: EE Intervention in Preterm
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm; Infant; Enriched Environment; Sensory; Motor; Development

Outcome Measures

Primary Outcomes (2)

• Motor Skills PDMS-2 Peabody Developmental Motor Scales 2nd Edition

  The Peabody Developmental Motor Scales 2nd Edition (PDMS-2): PDMS-2 evaluates fine and gross motor skills of children from birth to six years of age relative to their peers. There are four subtests on gross motor skills (Reflexes, stationary performances, locomotion, object manipulation) and two subtests on fine motor skills (Grasping, visual-motor integration). In the test, the skills to be assessed are listed in chronological order. The test starts at the child's age-appropriate beginner level (the level at which he gets 2 points on three items in a row) and ends when the child scores 0 on each of the three items in a row. Each item is scored as 0 (does not show performance criteria), 1 (shows some of the performance criteria), 2 (shows performance criteria) according to the child's performance, and the total score for each section is calculated at the end of the test.

  12 weeks

• Sensory Function

  Test of Sensory Functions in Infants™ (TSFI™): TSFI consists of 5 subtests and 24 items. The application time is approximately 20 minutes. In the subtests of the test, reactivity to tactile deep pressure, adaptive motor functions, visual-tactile integration, ocular-motor control, and reactivity to vestibular stimulation are evaluated and all items are scored. The infant is evaluated as normal, at-risk, or deficient in terms of sensory processing according to the total score he/she gets. A higher score indicates better sensory processing.

  12 weeks

Secondary Outcomes (1)

• Mental Health

  12 weeks

Study Arms (2)

Homeostasis-Enrichment-Plasticity

EXPERIMENTAL

HEP group will receive an environmental enrichment-based intervention.

Other: HEP

Traditional Physical Therapy

EXPERIMENTAL

TPT group will receive traditional physiotherapy intervention.

Other: Traditional Phsical Therapy

Interventions

HEP OTHER

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.

Homeostasis-Enrichment-Plasticity

Traditional Phsical Therapy OTHER

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

Traditional Physical Therapy

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• To be in corrected age between 4 and 10 months
• To being born 33 weeks and 6 days of gestation and before,
• To absence of any systemic disease, congenital anomaly,
• The family's volunteer to participate regularly in the study process.
• Having abnormal or suspect results on the Denver Developmental Screening Test II

You may not qualify if:

• To be born at or after 34 weeks of gestational age
• To having experienced intraventricular bleeding (Grade III and IV),
• To having major vision or hearing problems
• To having medical conditions that prevent active participation in the study (such as oxygen dependence)
• To participate in other experimental rehabilitation studies.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aymen Balıkçı, Asst. Prof.

  Fenerbahce University

  STUDY DIRECTOR

• Gamze Çağla Sırma

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 5, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

TU (1)