Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

U

Universidad de la Sabana

Status

Unknown

Conditions

Premature Birth

Treatments

Other: Interdisciplinary hospital-home intervention
Other: Convencional treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04563364
ENF-32-2019

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

34 to 37 weeks old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

130 participants in 2 patient groups

Hospital-Home
Experimental group
Description:
This group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development.
Treatment:
Other: Interdisciplinary hospital-home intervention
Control Intervention
Active Comparator group
Description:
Control group will receive a conventional treatment given by the institutions
Treatment:
Other: Convencional treatment

Trial contacts and locations

0

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Central trial contact

Carolina Sandoval, Mg.; Adriana L Castellanos, Mg.

Data sourced from clinicaltrials.gov

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