Clinical trial NCT06420635: Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol
Official title: Effect of an Interdisciplinary Intervention Program on Maternal Self-efficacy and Motor Development of Premature Children: Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Birth
Mothers of Newborn Infants
Keywords: Premature newborn
Mothers
self-efficacy
motor skills
motor praxis
outpatient care
information and communication technologies
kangaroo mother care
nursing
physical therapy
Lead sponsor: Universidad de la Sabana
Sponsor class: OTHER
Collaborators: name: Universidad de Boyacá
name: Hospital Universitario de La Samaritana
name: Universidade Franciscana (UFN)- Brasil
First posted: 2024-05-20
Enrollment: 92
Sex: ALL
Minimum age (years): 32
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; This requires promoting the positive perception of maternal self-efficacy and thus achieving the reinforcement of behaviors related to the demand for care in relation to motor development.

* Objective: Determine the effect of an interdisciplinary intervention program on maternal self-efficacy and motor development of premature children in the cities of Bogotá and Tunja in comparison with the traditional kangaroo program.
* Methodology: Experimental study, with pretest/posttest design, with experimental and control group, which determines the baseline. With initial evaluation of the groups, randomized assignment, and post-intervention evaluation at 4 weeks and flow-up at 8 weeks. The intervention will be developed in two scenarios, in the outpatient kangaroo plan consultation and at home. The experimental group will receive an intervention based on the promotion of maternal self-efficacy and the motor development of the premature baby. The control group will have traditional kangaroo program care. The sample calculation is 92 participants, 46 in the experimental group and 46 in the control group. The intervention, evaluations and data analysis will be developed by blinded professionals. An analysis of the data will be done by intention to treat.
* Type of results expected to be obtained: It is expected to obtain an intervention that promotes maternal self-efficacy for the adequate stimulation of the motor development of the premature baby. It is expected to enhance the confidence and empowerment of the maternal role, the motor development of children in accordance with the corrected age and the incorporation of ICT for monitoring at home.


Eligibility criteria: Inclusion Criteria:

* Mothers of a child born prematurely who attend the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025.
* Premature children between 32 to 36.6 weeks who participate in the outpatient kangaroo mother program in Bogotá, Tunja and Zipaquirá in the period between 2024 and 2025.

Exclusion Criteria:

* Mothers who manifest any diagnosed mental limitation to participate in the study.
* Premature children with hemodynamic alterations, congenital malformations, chromosomal syndromes, esophageal atresia, ductus arteriovenosus, heart disease and neurological pathologies.

Primary outcomes:
measure: Maternal self-efficacy
timeFrame: Two months
measure: Motor Development
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de la Sabana
name: Angélica Ospina, PhD
role: PRINCIPAL_INVESTIGATOR
References: