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OpenTrials
Completed

NCT Number: NCT04693494

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

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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Key information

Conditions

Term Development, Infant Healthy Motor Delay Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms

Age range

1 day–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Jorge

Zaragoza, Aragon, 50019, Spain

About this study

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:

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

Control group:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training program

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.

Primary outcomes

  1. Score of the Alberta Infant Motor Scale (AIMS) at month 9

    Time frame: 9 months old

    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.

  2. Score of the Alberta Infant Motor Scale (AIMS) at month 12

    Time frame: 12 months old

    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.

  3. Score of the Alberta Infant Motor Scale (AIMS) at month 15

    Time frame: 15 months old

    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.

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Jan 5, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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