## Protocol Section
### Identification Module
**NCT ID:** NCT06420635

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ENF-64-2022
#### Organization
**Class:** OTHER
**Full Name:** Universidad de la Sabana
### Status Module
#### Completion Date
**Date:** 2025-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-25

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-25

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Universidad de Boyacá

**Class:** UNKNOWN

**Name:** Hospital Universitario de La Samaritana

**Class:** UNKNOWN

**Name:** Universidade Franciscana (UFN)- Brasil

#### Lead Sponsor

**Class:** OTHER

**Name:** Universidad de la Sabana

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 92

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** Interdisciplinary intervention program on maternal self-efficacy and motor development

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Behavioral: Traditional kangaroo program

**Label:** Traditional Kangaroo Program

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interdisciplinary intervention program on maternal self-efficacy and motor development

**Description:** The experimental group will receive an intervention about maternal self-efficacy and motor stimulation strategies for premature children applied by mothers. There will be two face-to-face meetings: the first with a theoretical session on motor development, a practical workshop on stimulation skills using a baby simulator and strengthening of maternal self-efficacy. The second meeting seeks for mothers to reflect on self-efficacy and carry out practical simulation of strategies with their children. At home (for four weeks), self-efficacy will be strengthened through 4 strategies twice a week, for 8 sessions. Mothers will put into practice with the baby the 10 stimulation strategies explained in the face-to-face sessions, must complete 14 sessions per week, 2 times a day, for a total of 56 sessions. The initial measurement will be carried out before the intervention, the second at 4 weeks and the third at 8 weeks after the intervention began.

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

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Traditional Kangaroo Program

**Description:** The control group will receive the conventional family-centered care plan, including kangaroo position, exclusive breastfeeding, and outpatient follow-up. The traditional intervention for the control group is based on the Kangaroo Mother Method (KMC) program, proposed according to technical guidelines, which promotes skin-to-skin contact between mother and premature baby. In periodic outpatient consultations, clinical assessments are carried out focused on optimal growth (goal 15-20g/kg/day), neurological and psychomotor development, and timely detection of pathologies that require specialized care according to findings. Compliance with the vaccination schedule and medical indications, and assurance of breastfeeding, are monitored. The frequency of check-ups is daily initially, then weekly until 40 weeks and then monthly. The approach includes early stimulation and follow-up until 12 months of corrected age.

**Name:** Traditional kangaroo program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Maternal self-efficacy

**Time Frame:** Two months

**Description:** 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.

**Measure:** Motor Development

**Time Frame:** Two months

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 37 Weeks

**Minimum Age:** 32 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** angelica.ospina@unisabana.edu.co

**Name:** Angélica Ospina, PhD

**Phone:** +573106095732

**Role:** CONTACT

**Contact 2:**

**Email:** empinto@uniboyaca.edu.co

**Name:** Erika Pinto, RN

**Phone:** +573003385739

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Universidad de la Sabana

**Name:** Angélica Ospina, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-31
