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Interdisciplinary Hospital-home Intervention on Motor Development in Premature Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04563364
Enrollment
130
Registered
2020-09-24
Start date
2021-10-01
Completion date
2024-07-29
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Infant, Child Development, Nursing, Physical Therapy Specialty

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.

Interventions

OTHERInterdisciplinary 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

Control group will receive a conventional treatment given by the institutions

Sponsors

Universidad de la Sabana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
34 Weeks to 37 Weeks
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Motor Development.18 MonthsTest on infant motor performance (TIMPSI)

Secondary

MeasureTime frameDescription
CapDMP questionnaireFrom enrollment to the end of treatmentQuestionnaire that measure the degree of knowledge in parents or caregivers about motor development in premature

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026