Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

Healthy Clinical Trial

Official title:

Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693494
• Other study ID #: ufernandez2020
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: January 17, 2023

Study information

• Verified date: May 2024
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study compares motor development of two groups of healthy term babies at the end of their first year of life. Parents of the intervention group have received a training program consisting in advices about correct positions, stimuli, how to play or how to carry their babies. The purpose of this study is to know if motor development can be improved by the environment.

Description:

Infants in both groups are recruited by the principal investigator at the hospital within two to three days after birth. An initial assessment was carried out at 2 months of age.

Intervention group:

1. Four training sessions (before the baby is 1 month old, at 3 months, at 6, and at 9 months old) teaching the main motor milestones to get in the next 3 months and how to help infants with the correct stimuli, positions or plays; triptychs containing the main points explained at the session and links to short videos about the given bits of advice.

2. Three evaluations of motor milestones at 9, 12, and 15 months old.

Control group:

1. Three evaluations of motor milestones at 9, 12, and 15 months old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 17, 2023
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 9 Months

Eligibility

Inclusion Criteria:

• Healthy-term infants

• Male and female

• Apgar score of at least 7 in the first minute and at five minutes.

• Natural or cesarean birth

• Absence of congenital malformations or orthopedic injury

• Absence of known congenital or genetic pathology

• Normal neurological medical examination of the newborn at hospital discharge.

Exclusion Criteria:

• Newborns who have required hospitalization before being enrolled.

• Multiple births

Related Conditions & MeSH terms

• Development, Infant
• Healthy
• Motor Delay
• Term

Intervention

Other:
• Training program
Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of the Alberta Infant Motor Scale (AIMS) at month 9	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.	9 months old
Primary	Score of the Alberta Infant Motor Scale (AIMS) at month 12	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.Depending on the score, the percentile is obtained.	12 months old
Primary	Score of the Alberta Infant Motor Scale (AIMS) at month 15	AIMS is a validated observational scale for measurement of motor milestones. Higher scores mean a better outcome. Depending on the score, the percentile is obtained.	15 months old