Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol

Not Applicable

Not yet recruiting

• Conditions: Premature Birth; Mothers of Newborn Infants
• Interventions: Behavioral: Traditional kangaroo program; Behavioral: Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children

• Registration Number: NCT06420635
• Lead Sponsor: Universidad de la Sabana

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Study Start: 2024-06-25
• Primary Completion: 2025-09-25
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Kangaroo Program	Traditional kangaroo program	The control group will receive the conventional family-centered care plan, including kangaroo position, exclusive breastfeeding, and monitoring of the child's progress.
Interdisciplinary intervention program on maternal self-efficacy and motor development	Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children	Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children.

Primary Outcome Measures

Name	Time	Method
Motor Development	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	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.