Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
Primary Purpose
Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Interdisciplinary hospital-home intervention
Convencional treatment
Sponsored by

About this trial
This is an interventional treatment trial for Premature Birth focused on measuring Infant, Child Development, Nursing, Physical Therapy Specialty
Eligibility Criteria
Inclusion Criteria:
- Premature infants between 34 and 37 weeks of gestation,
- Infants with weight over 1800gr
- Hemodynamic stability
- Interns in NICU of participants institutions (Colombia and Poland).
- Infants with residence in a places close to the institutional health care services.
Exclusion Criteria:
- Premature child with a musculoskeletal deformity.
- Premature child with diagnosis of a genetic syndrome
- Premature child with congenital heart diseases.
- Premature child with brain injuries.
Sites / Locations
- Hospital San Rafael
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hospital-Home
Control Intervention
Arm Description
This group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development.
Control group will receive a conventional treatment given by the institutions
Outcomes
Primary Outcome Measures
Motor Development.
Test on infant motor performance (TIMPSI)
Secondary Outcome Measures
Full Information
NCT ID
NCT04563364
First Posted
August 25, 2020
Last Updated
September 18, 2020
Sponsor
Universidad de la Sabana
1. Study Identification
Unique Protocol Identification Number
NCT04563364
Brief Title
Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
Official Title
Interdisciplinary Hospital-home Intervention on the Adaptation of Motor Development in Premature Children.Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
December 27, 2021 (Anticipated)
Study Completion Date
April 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de la Sabana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Motor development of the premature infant often exhibits deviations that trigger functional limitations and disability. In Colombia, one out of every five births corresponds to premature babies. In preterm infants requiring hospitalization, early clinical interventions focused on home care have been shown to improve motor development and decrease morbidity.
However, interdisciplinary work, supported by information and communication Technologies (ICT), shows a knowledge gap that can be explored. This leads to the following research question: What is the effect of the Interdisciplinary Hospital-Home Intervention on the adaptation of the motor development of premature children compared to traditional intervention in Colombia and Polonia?
Objective: To determine the effect of the interdisciplinary Hospital-Home intervention on the adaptation of the motor development of premature children compared to traditional intervention in Colombia and Polonia
Methodology Experimental quantitative study with pre-test and post-test to two groups, experimental and control, which compares before and after the intervention. The intervention will be developed in two scenarios: the hospital and the home. The experimental group will receive the intervention and the control group the traditional care established in the institutions for premature children. The calculation of the sample size is 130 participants.
Type of results expected to be obtained It is expected to obtain a supported that justifies the importance of education from hospital stay, post discharge follow-up and parental participation in the adequate stimulation of motor development of the premature. It is expected to incorporate the use of ICT in home monitoring, while implementing the use of a mobile application for this purpose. It is also expected to contribute to the research training of undergraduate and graduate students. In addition, participate in national and international presentations and in the production of scientific articles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Infant, Child Development, Nursing, Physical Therapy Specialty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hospital-Home
Arm Type
Experimental
Arm Description
This group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development.
Arm Title
Control Intervention
Arm Type
Active Comparator
Arm Description
Control group will receive a conventional treatment given by the institutions
Intervention Type
Other
Intervention Name(s)
Interdisciplinary hospital-home intervention
Intervention Description
The intervention will start in NICU and to be continued at home with the support of ICT. The NICU intervention will have theoretical and practical components, the theoretical one will be about motor development in premature infants, and practical one will have strategies for motor early intervention, it will be demonstrated with pediatric simulator and parents should be demonstrate it with a infant: 1Sensorial motor stimulation, visual and auditory follow-6up; Tactile integration 3Extension muscle activation 4Middle line integration 5Alignment reaction stimulation in prone position 6Flexor muscle activation with transition to lateral position 7Flexor muscle activation with transition to sitting position 8Facilitation of reciprocal flexion and extension lower limbs. All parents will receive a motor sensorial kit that will include roller, visual tags, blankets and rattles, it will be for apply the strategies for motor early intervention, and will be supported by ICT
Intervention Type
Other
Intervention Name(s)
Convencional treatment
Intervention Description
Control group will receive a conventional treatment given by the institutions
Primary Outcome Measure Information:
Title
Motor Development.
Description
Test on infant motor performance (TIMPSI)
Time Frame
18 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Premature infants between 34 and 37 weeks of gestation,
Infants with weight over 1800gr
Hemodynamic stability
Interns in NICU of participants institutions (Colombia and Poland).
Infants with residence in a places close to the institutional health care services.
Exclusion Criteria:
Premature child with a musculoskeletal deformity.
Premature child with diagnosis of a genetic syndrome
Premature child with congenital heart diseases.
Premature child with brain injuries.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana L Castellanos, Mg.
Phone
+573173755780
Email
adriana.castellanos@unisabana.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Sandoval, Mg.
Phone
+573124496799
Email
carolinasandoval@uniboyaca.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana L Castellanos, Mg.
Organizational Affiliation
Universidad de la Sabana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Rafael
City
Tunja
Country
Colombia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana L Castellanos, Mg
Phone
+573173755780
Email
adriana.castellanos@unisabana.edu.co
12. IPD Sharing Statement
Plan to Share IPD
No
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Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children
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