Premature BirthNCT03232190
The Use of an Age-linked App for Parents During and After a NICU Stay
A study testing Web Application in people with Premature Birth, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Web Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2014to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature birth (< 32 weeks)
Who cannot join
- The lack of internet access or a personal email account
- Little or no knowledge of Dutch in both parents
- Children with a congenital disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg, Schiepse Bos 6
Genk, Limburg, 3600
About this study
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
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.
- Conditions
- Premature Birth
- Being tested
- Web Application
- Keywords
- prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web ApplicationOther
Parents receive a web application that offers information and support until the age of 2.
| Study group | Role | What they receive |
|---|---|---|
| INTNIC | Experimental | NICU Intervention Group Web Application Infants < 32 weeks Receives: Other: Web Application |
| CNIC | No intervention | NICU Control Group No Web Application Infants < 32 weeks |
| CMAT | No intervention | Maternity Unit Control Group No Web Application Infants > 37 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bayley-III-NL
Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Measured: 5 months, 1 year, 2 year
Change in DT-P
Distress Thermometer for Parents
Measured: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Change in EMPO
Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
Measured: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
WPPSI-III-NL
Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
Measured: 5 year
Secondary outcomes (1)
Change in PNAR
Parent Newborn Attachment Relationship Questionnaire
Measured: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startJan 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, TRACE: Centre For Translational Psychological Research
- Responsible party
- Principal investigator, Marie-Rose Van Hoestenberghe, MD, Ziekenhuis Oost-Limburg
- Investigators
- Marie-Rose Van Hoestenberghe, MD., Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232190
- Sponsor's protocol ID
- B331201422729
- Status last verified
- Jul 2019
- First submitted
- 16 Feb 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03232190
- Acronym / sponsor ID
- B331201422729
- Conditions
- Premature Birth
- Keywords
- prematurity, psychomotor development, parent empowerment, e-health, parental support, post discharge follow-up
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- KU Leuven, TRACE: Centre For Translational Psychological Research
- Study start
- Jan 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INTNIC | Experimental | Other: Web ApplicationNICU Intervention Group Web Application Infants < 32 weeks |
| CNIC | No intervention | –NICU Control Group No Web Application Infants < 32 weeks |
| CMAT | No intervention | –Maternity Unit Control Group No Web Application Infants > 37 weeks |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature birth (< 32 weeks)
Key exclusion criteria (3 listed)
- The lack of internet access or a personal email account
- Little or no knowledge of Dutch in both parents
- Children with a congenital disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web ApplicationParents receive a web application that offers information and support until the age of 2. | Other | INTNIC |
Primary outcome
Change in Bayley-III-NL
Time frame: 5 months, 1 year, 2 year
Bayley Scales of Infant and Toddler Development Mental, social and motor development of the child
Change in DT-P
Time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Distress Thermometer for Parents
Change in EMPO
Time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Dutch Empowerment Questionnaire Parental empowerment in raising children (intrapersonal, interactional, and behavioral)
WPPSI-III-NL
Time frame: 5 year
Wechsler Preschool and Primary Scale of Intelligence Cognitive Development of the Child
1 secondary outcome
Change in PNAR
Time frame: 2 weeks after birth, 37 weeks PMA, 5 months, 1 year, 2 year, 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Rose Van Hoestenberghe, MD. principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Application in people with Premature Birth, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Rose Van Hoestenberghe, MD. (+32 89 32 76 33, marie-rose.vanhoestenberghe@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bayley-III-NL (time frame: 5 months, 1 year, 2 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.