Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

Premature Birth Clinical Trial

Official title:

Interdisciplinary Hospital-home Intervention on the Adaptation of Motor Development in Premature Children.Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04563364
• Other study ID #: ENF-32-2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 29, 2022

Study information

• Verified date: September 2020
• Source: Universidad de la Sabana
• Contact: Adriana L Castellanos, Mg.
• Phone: +573173755780
• Email: adriana.castellanos[@]unisabana.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: April 29, 2022
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 37 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Interdisciplinary hospital-home intervention
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
• Convencional treatment
Control group will receive a conventional treatment given by the institutions

Locations

Country	Name	City	State
Colombia	Hospital San Rafael	Tunja

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de la Sabana

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Development.	Test on infant motor performance (TIMPSI)	18 Months