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

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ClinicalTrials.gov Identifier: NCT04693494
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Luis Fernandez, Universidad San Jorge

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Term Healthy Motor Delay Development, Infant Other: Training program Not Applicable

Detailed Description:

infants of the intervention group are enrolled by the main investigator in the hospital in the next two or three days after birth. Infants of the control group are enrolled by the pediatricians at the age of 9 months old in the Primary Care Service.

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 advices.
  2. Two evaluations of motor milestones at the age of 9 and 12 months old.

Control group:

1. Two evaluations of motor milestones at the age of 9 and 12 months old.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention and control group.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effectiveness of a Training Program for Parents of Babies in Their First Year of Life to Achieve Motor Milestones
Actual Study Start Date : December 1, 2019
Actual Primary Completion Date : December 7, 2020
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

Two evaluations of motor milestones at the age of 9 and 12 months old

 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.
No Intervention: Control group
Two evaluations of motor milestones at the age of 9 and 12 months old


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy term infants
  • Male and female
  • 9 months old for the control group, less than 1 week old for the intervention group.
  • Apgar score of at least 7 the first minute and at five minutes.
  • Natural or cesarean birth
  • With or without in vitro fertilization
  • Absence of congenital malformations or orthopedic injury
  • Absence of known congenital or genetic pathology
  • Normal neurological medical examination of the newborn at hospital discharge or at first medical examination in the Primary Care Service

Exclusion Criteria:

  • Newborns who have required hospitalization before being enrolled (intervention group) or sometime until 9 months old (control group).
  • Multiple birth
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693494


Contacts
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Contact: Luis Fernández Sola, Physical Th +34615674867 ufernandez@usj.es

Locations
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Spain
Universidad San Jorge Recruiting
Zaragoza, Aragón, Spain, 50019
Contact: Luis Fernández    +34615674867    ufernandez@usj.es   
Sponsors and Collaborators
Universidad San Jorge
Investigators
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Principal Investigator: Luis Fernández Sola, Physical Th Universidad San Jorge
Study Director: Beatriz Cano Díez, Physical Th Universidad San Pablo CEU
More Information
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Responsible Party: Luis Fernandez, Physical therapist, Universidad San Jorge
ClinicalTrials.gov Identifier: NCT04693494    
Other Study ID Numbers: ufernandez2020
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD after deidentified
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 5 years
Access Criteria: Información will be shared with editors or other investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Fernandez, Universidad San Jorge:
motor milestones
term
newborn
motor development