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The Use of an Age-linked App for Parents During and After a NICU Stay

The Use of an Age-linked Web Application for Parents During and After a NICU Stay in Improving Child Development and Parent Empowerment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03232190
Enrollment
180
Registered
2017-07-27
Start date
2014-01-31
Completion date
2022-12-31
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up

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.

Interventions

Parents receive a web application that offers information and support until the age of 2.

Sponsors

KU Leuven
CollaboratorOTHER
TRACE: Centre For Translational Psychological Research
CollaboratorUNKNOWN
Ziekenhuis Oost-Limburg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Bayley-III-NL5 months, 1 year, 2 yearBayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Change in DT-P2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 yearDistress Thermometer for Parents
Change in EMPO2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 yearDutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
WPPSI-III-NL5 yearWechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child

Secondary

MeasureTime frameDescription
Change in PNAR2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 yearParent Newborn Attachment Relationship Questionnaire

Countries

Belgium

Contacts

Primary ContactMarie-Rose Van Hoestenberghe, MD.
marie-rose.vanhoestenberghe@zol.be+32 89 32 76 33

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026