Clinical trial NCT04563364: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Keywords: Infant
Child Development
Nursing
Physical Therapy Specialty
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 130
Sex: ALL
Minimum age (years): 34
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions?

Objective: To determine the effect of an interdisciplinary Hospital-Home intervention addressing motor development adaptation in premature infants in Colombia in comparison with traditional interventions

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.


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.

Primary outcomes:
measure: Motor Development.
timeFrame: 18 Months
Secondary outcomes:
measure: CapDMP questionnaire
timeFrame: From enrollment to the end of treatment
Other outcomes:
Locations:
city: Tunja
country: Colombia
facility: Hospital San Rafael
Study officials:
affiliation: Universidad de la Sabana
name: Adriana L Castellanos, Mg.
role: PRINCIPAL_INVESTIGATOR
References: