Effect of an Interdisciplinary Intervention Program on Maternal Self-efficacy and Motor Development of Premature Children: Clinical Trial Protocol

Universidad de la Sabana0 sites92 target enrollmentJune 25, 2024

ConditionsPremature Birth Mothers of Newborn Infants

Overview

Phase: N/A
Intervention: Not specified
Conditions: Premature Birth
Sponsor: Universidad de la Sabana
Enrollment: 92
Primary Endpoint: Motor Development
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2024

End Date

December 15, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad de la Sabana

Responsible Party

Sponsor

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
•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.

Outcomes

Primary Outcomes

Motor Development

Time Frame: Two months

Alberta Infant Motor Scale (EMIA). The total score is 90, the minimum value is 5, and the maximum is 90. Higher scores indicate a greater motor development, which is directly proportional to the corrected age of children.

Maternal self-efficacy

Time Frame: Two months

Parental Evaluation Scale (PES). The total score is 10, the minimum value is 0, and the maximum is 10. Higher scores indicate a greater perception of self-efficacy and maternal satisfaction.