Explorer Babies Early Intervention Program

NCT04203589 | Completed

• 1 other identifier: 09.2017.729
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Premature babies have a high risk of adverse developmental outcomes. Early intervention approaches are applied to reduce these adverse outcomes or support of developmental delay. Early intervention approaches may vary depending on developmental priorities. While some early intervention methods can consider body structured findings such as posture, tonus, muscle power, others may consider coaching family, enrichment of the environment. The explorer baby program is developed based on the trial and error process. The program tries to find an answer to a unique question: "how trial behavior in infants can be increased and which behaviors of the infants should be supported to increase their trial process?" The Explorer baby program tries to increase exploratory motor behaviors to facilitate development. For this aim, the program tries to explain how a baby learns new skills such as rolling, sitting, babbling, playing peek a boo, etc. in all domains of development while the baby lives in their natural environment. This study aims to investigate the effect of the explorer baby early intervention program.

Conditions

Premature; Developmental Disability; Cerebral Palsy; Motor Disorders; Development, Infant

Keywords

Premature; Developmental Disability; Motor Disorder; Cerebral Palsy; Early Intervention; developmental Support

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)

  The Bayley III is assessing "Cognitive, Receptive Language, Expressive Language, Fine Motor, Gross Motor". Bayley III has a raw score, scale score, composite score, and growth percentile score. All of these scores will be given in the study. But only, the growth percentage score will be discussed as both the subareas and the total score as the primary outcome. Because only the percentage of growth gives the baby's level of development exactly day by day. The percentile score is between 0 and 100. A higher score means improvement is better. The changes in the growth percentage in pre-test and post-test (T0-T1, T1-T2, T0-T2) will be examined in-group. Also, the growth percentage scores of two groups will be compared before, during and after the therapy (intergroup). This tool will be used to assess the change between the three-time points.

  This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

Secondary Outcomes (3)

• Age and Stage Questionnaire 2 (ASQ-2)

  This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

• Parent Stress Index-4-Short Form (PSI SF-4)

  This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

• Infant Movement Motivation Questionnaire

  This tool will be used to assess the change between the three-time points. These time points are before therapy (T0), during therapy (T1 - 3 months after T0) and after therapy (T2 - 6 months after T0)

Study Arms (2)

The Explorer Early Intervention Program

EXPERIMENTAL

The Explorer Early Intervention Program is used in this group.

Behavioral: The Explorer Baby Early Intervention Program

Neurodevelopmental Therapy

ACTIVE COMPARATOR

Neurodevelopmental therapy is used in these group by two experienced and certificated physiotherapist

Other: Neurodevelopmental Therapy

Interventions

The Explorer Baby Early Intervention Program BEHAVIORAL

Centered based intervention, once or twice a month, 6 months follow up

Also known as: Explorer Baby

The Explorer Early Intervention Program

Neurodevelopmental Therapy OTHER

Centered based intervention, once or twice a month, 6 months follow up

Also known as: Bobath

Neurodevelopmental Therapy

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born before than 33 weeks

You may not qualify if:

• congenital malformations, all levels of asphyxia, intracranial hemorrhage, periventricular leukomalacia.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (3)

• Babik I, Galloway JC, Lobo MA. Infants Born Preterm Demonstrate Impaired Exploration of Their Bodies and Surfaces Throughout the First 2 Years of Life. Phys Ther. 2017 Sep 1;97(9):915-925. doi: 10.1093/ptj/pzx064.

  PMID: 28605484 BACKGROUND

• de Campos AC, Savelsbergh GJ, Rocha NA. What do we know about the atypical development of exploratory actions during infancy? Res Dev Disabil. 2012 Nov-Dec;33(6):2228-35. doi: 10.1016/j.ridd.2012.06.016. Epub 2012 Jul 21.

  PMID: 22820063 BACKGROUND

• Altunalan T, Sari Z, Dogan TD, Hacifazlioglu NE, Akman I, Altintas T, Uzer S, Akcakaya NH. Early developmental support for preterm infants based on exploratory behaviors: A parallel randomized controlled study. Brain Behav. 2023 Nov;13(11):e3266. doi: 10.1002/brb3.3266. Epub 2023 Oct 5.

  PMID: 37798860 DERIVED

MeSH Terms

Conditions

Premature Birth; Developmental Disabilities; Cerebral Palsy; Motor Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Zübeyir Sarı, PhD

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A parallel randomized controlled study

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 18, 2019
• Study Start: June 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: April 30, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)