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

NANot yet recruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

June 25, 2024

Primary Completion Date

September 25, 2025

Study Completion Date

December 15, 2025

Conditions
Premature BirthMothers of Newborn Infants
Interventions
BEHAVIORAL

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

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.

BEHAVIORAL

Traditional kangaroo program

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.

All Listed Sponsors
collaborator

Universidad de Boyacá

OTHER

collaborator

Hospital Universitario de La Samaritana

UNKNOWN

collaborator

Universidade Franciscana (UFN)- Brasil

UNKNOWN

lead

Universidad de la Sabana

OTHER

NCT06420635 - Maternal Self-efficacy and Motor Development in Premature Infants: Clinical Trial Protocol | Biotech Hunter | Biotech Hunter