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

Universidad de la Sabana

Status: Not yet enrolling

Conditions: Mothers of Newborn Infants; Premature Birth

Treatments: Behavioral: Traditional kangaroo program; Behavioral: Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children

Study type: Interventional

Funder types: Other

Identifiers

NCT06420635

ENF-64-2022

Details and patient eligibility

About

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.

Enrollment: 92 estimated patients

Sex: All

Ages: 32 to 37 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 2 patient groups

Interdisciplinary intervention program on maternal self-efficacy and motor development

Experimental group

Description:

Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children.

Treatment:

Behavioral: Interdisciplinary intervention program on maternal self-efficacy and the motor development of premature children

Traditional Kangaroo Program

Active Comparator group

Description:

The control group will receive the conventional family-centered care plan, including kangaroo position, exclusive breastfeeding, and monitoring of the child's progress.

Treatment:

Behavioral: Traditional kangaroo program