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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-01-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Term Healthy Motor Delay Development, Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention and control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double blinded: spontaneous behavior of babies is evaluated, that doesn't depend of having knowledge of the intervention. Outcomes assessor doesn't know the evaluated baby group.

Study Groups

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Intervention group

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 advices.

Three evaluations of motor milestones at the age of 9, 12, and 15 months old

Group Type EXPERIMENTAL

Training program

Intervention Type OTHER

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.

Control group

Three evaluations of motor milestones at the age of 9, 12, and 15 months old

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.