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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05410639
Other study ID # 09.2020.1352
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2021
Est. completion date March 18, 2022

Study information

Verified date December 2021
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.


Description:

Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date March 18, 2022
Est. primary completion date March 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 8 Months
Eligibility Inclusion Criteria: - infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment. - Being a premature baby born at or under 32 weeks - infant corrected age between 0-8 months - To agree to participate in the study. Exclusion Criteria: - Having a concomitant major anomaly and genetic disease - The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
online education program
The training we provided was to give exercises and advice to parents according to the age of the baby in order to stimulate the motor and social development of the baby,and then, an improvement in the stress state of the parents by their participation in the care of their baby.The training, which began with the discharge of the baby from the hospital, was in the form of slide presentations and videos.
no online education program
Parents and their infants in the control group did not receive any online education program

Locations

Country Name City State
Turkey Marmara University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alberta Infant Motor Scale (AIMS) AIMS assesses the gross infant motor skills in supine, prone, sitting and standing positions with 58 items.the child is scored dec 0 to 58 points and evaluated with age-appropriate percentile curves:0-10 atypical development, 11-25 questionable performance, 26-75 normal performance, 76-90 very good performance, 91-100 are classified as excellent performance. Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
Primary The Social-Communication Area Screening Test of Infant (SCASI) SCASI assesses the social-communication infant skills,filled by the parents.it is an original and fast test for the early identification and evaluation of children at developmental risk in infancy and early childhood up to the age of 6-24 months. Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
Secondary Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF) PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfonctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant. Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
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