The Use of an Age-linked App for Parents During and After a NICU Stay
Primary Purpose
Premature Birth
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Web Application
Sponsored by
About this trial
This is an interventional supportive care trial for Premature Birth focused on measuring prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up
Eligibility Criteria
Inclusion Criteria:
- Premature birth (< 32 weeks)
Exclusion Criteria:
- The lack of internet access or a personal email account
- Little or no knowledge of Dutch in both parents
- Children with a congenital disease
Sites / Locations
- Ziekenhuis Oost-Limburg, Schiepse Bos 6Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
INTNIC
CNIC
CMAT
Arm Description
NICU Intervention Group Web Application Infants < 32 weeks
NICU Control Group No Web Application Infants < 32 weeks
Maternity Unit Control Group No Web Application Infants > 37 weeks
Outcomes
Primary Outcome Measures
Change in Bayley-III-NL
Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Change in DT-P
Distress Thermometer for Parents
Change in EMPO
Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
WPPSI-III-NL
Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
Secondary Outcome Measures
Change in PNAR
Parent Newborn Attachment Relationship Questionnaire
Full Information
NCT ID
NCT03232190
First Posted
February 16, 2017
Last Updated
July 30, 2019
Sponsor
Ziekenhuis Oost-Limburg
Collaborators
KU Leuven, TRACE: Centre For Translational Psychological Research
1. Study Identification
Unique Protocol Identification Number
NCT03232190
Brief Title
The Use of an Age-linked App for Parents During and After a NICU Stay
Official Title
The Use of an Age-linked Web Application for Parents During and After a NICU Stay in Improving Child Development and Parent Empowerment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg
Collaborators
KU Leuven, TRACE: Centre For Translational Psychological Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of the neonatal intensive care unit (NICU) is to optimize the development of the newborn. Preterm children are at greater risk for developmental disorders. On the one hand, this is due to cerebral complications inherent to the prematurity, on the other hand it is related to the very early and therefore vulnerable stage of brain development at the time of the premature birth. The development of the child is also the result of a constant interaction between the infant and its environment, primarily the primary caregiver (i.e. the parents). A premature birth can cause great stress to parents, and there are several obstacles that can make it difficult to handle their child. Therefore, we have developed a web application that supports parents until their child reaches the age of two. By keeping them informed, we hope to make them more confident in their role as parents, and thus facilitate the parent-child interaction. In order to determine whether this form of support has an additional effect on the development of the premature child, we compare two groups of premature infants and a group of non-premature infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INTNIC
Arm Type
Experimental
Arm Description
NICU Intervention Group Web Application Infants < 32 weeks
Arm Title
CNIC
Arm Type
No Intervention
Arm Description
NICU Control Group No Web Application Infants < 32 weeks
Arm Title
CMAT
Arm Type
No Intervention
Arm Description
Maternity Unit Control Group No Web Application Infants > 37 weeks
Intervention Type
Other
Intervention Name(s)
Web Application
Intervention Description
Parents receive a web application that offers information and support until the age of 2.
Primary Outcome Measure Information:
Title
Change in Bayley-III-NL
Description
Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Time Frame
5 months, 1 year, 2 year
Title
Change in DT-P
Description
Distress Thermometer for Parents
Time Frame
2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Title
Change in EMPO
Description
Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
Time Frame
2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Title
WPPSI-III-NL
Description
Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Change in PNAR
Description
Parent Newborn Attachment Relationship Questionnaire
Time Frame
2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature birth (< 32 weeks)
Exclusion Criteria:
The lack of internet access or a personal email account
Little or no knowledge of Dutch in both parents
Children with a congenital disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Rose Van Hoestenberghe, MD.
Phone
+32 89 32 76 33
Email
marie-rose.vanhoestenberghe@zol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Rose Van Hoestenberghe, MD.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg, Schiepse Bos 6
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Use of an Age-linked App for Parents During and After a NICU Stay
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