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

U

Universidad San Jorge

Status

Completed

Conditions

Healthy
Term
Motor Delay
Development, Infant

Treatments

Other: Training program

Study type

Interventional

Funder types

Other

Identifiers

NCT04693494
ufernandez2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 patients

Sex

All

Ages

1 day to 9 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 2 patient groups

Intervention group
Experimental group
Description:
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
Treatment:
Other: Training program
Control group
No Intervention group
Description:
Three evaluations of motor milestones at the age of 9, 12, and 15 months old

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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