Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

NCT04563364 | Completed

• 1 other identifier: ENF-32-2019
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Infant; Child Development; Nursing; Physical Therapy Specialty

Outcome Measures

Primary Outcomes (1)

• Motor Development.

  Test on infant motor performance (TIMPSI)

  18 Months

Secondary Outcomes (1)

• CapDMP questionnaire

  From enrollment to the end of treatment

Study Arms (2)

Hospital-Home

EXPERIMENTAL

This group will receive an interdisciplinary intervention of education to parents for get better outcomes of motor development.

Other: Interdisciplinary hospital-home intervention

Control Intervention

ACTIVE COMPARATOR

Control group will receive a conventional treatment given by the institutions

Other: Convencional treatment

Interventions

Interdisciplinary hospital-home intervention OTHER

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

Hospital-Home

Convencional treatment OTHER

Control group will receive a conventional treatment given by the institutions

Control Intervention

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de la Sabana: lead

Study Sites (1)

Hospital San Rafael

Tunja, Colombia

Location

Related Publications (1)

• Sandoval-Cuellar C, Castellanos-Garrido AL, Ospina Romero AM, Boude Figueredo OR, Serrano-Gomez ME, Fuya Caro CA, Molina Cardenas DC, Pinto Rosas EM. Motor development in premature infants: Study protocol for an interdisciplinary hospital-home intervention. Pediatr Neonatol. 2023 Sep;64(5):577-584. doi: 10.1016/j.pedneo.2022.12.015. Epub 2023 Mar 15.

  PMID: 37002053 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adriana L Castellanos, Mg.

  Universidad de la Sabana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2021
• Primary Completion: March 15, 2023
• Study Completion: July 29, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)