Cleft LipNCT02415361
Follow Ups of Parents With Infants With Cleft Lip and Palate
A study testing Cleft lip and palate in people with Cleft Lip and Cleft Palate, run by Oslo University Hospital at 1 site in Norway.
Trial summary
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip, Cleft Palate
- What is being tested?
- Cleft lip and palate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
- Birthplace in south-east region of Norway
- Scandinavian speaking parents
Who cannot join
- Parents of infants with CLP who are referred to the hospital after the first measure point
- Birthplace outside south-east region of Norway
- Non-scandinavian speaking parents
Trial locations and contacts
1 site in 1 country.
About this study
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.
- Conditions
- Cleft Lip, Cleft Palate
- Being tested
- Cleft lip and palate
- Keywords
- Parents, Follow-Up Studies
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleft lip and palateOther
Comparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | Standard care consists of: * a phone call from a CLP-nurse after the referral from the local birth hospital has been received * telephone service at parents request and at the staffs availability * invitation to a one-day-information course before surgery |
| Arm B | Active comparator | Systematic follow up by a special trained nurse consists of:
* telephone contact with the parents shortly after birth
* visit at the maternity ward within 36 hours after the referral has been received
* telephone follow ups at specific times and at parents request
* guidance and support in feeding and treatment
* written information
* cooperation with the staff at the maternity unit and the health centre
* follow up in accordance with a check-list and log
* invitation to a one-day-information course before surgery Receives: Other: Cleft lip and palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Measured: 1 month post partum
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
Both Groups
Measured: 1 month post partum
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
Both groups
Measured: 1 month post partum
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
Both groups
Measured: 1 month post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Measured: 1 month post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Measured: 6 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Measured: 6 months post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Measured: 13 months post partum
Infant growth as measured by "Child health card"
Both groups
Measured: 13 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Measured: 13 months post partum
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
Both groups
Measured: 6 months post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Alexander Tønseth, Oslo University Hospital
- Investigators
- Kim A Tønseth, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415361
- Sponsor's protocol ID
- 2014/17828
- Other IDs
- 2014
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2015
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow Ups of Parents With Infants With Cleft Lip and Palate
- ClinicalTrials.gov ID
- NCT02415361
- Acronym / sponsor ID
- 2014/17828
- Conditions
- Cleft Lip, Cleft Palate
- Keywords
- Parents, Follow-Up Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Standard care consists of: * a phone call from a CLP-nurse after the referral from the local birth hospital has been received * telephone service at parents request and at the staffs availability * invitation to a one-day-information course before surgery |
| Arm B | Active comparator | Other: Cleft lip and palateSystematic follow up by a special trained nurse consists of: * telephone contact with the parents shortly after birth * visit at the maternity ward within 36 hours after the referral has been received * telephone follow ups at specific times and at parents request * guidance and support in feeding and treatment * written information * cooperation with the staff at the maternity unit and the health centre * follow up in accordance with a check-list and log * invitation to a one-day-information course before surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
- Birthplace in south-east region of Norway
- Scandinavian speaking parents
Key exclusion criteria (3 listed)
- Parents of infants with CLP who are referred to the hospital after the first measure point
- Birthplace outside south-east region of Norway
- Non-scandinavian speaking parents
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 |
|---|---|---|
| Cleft lip and palateComparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed. | Other | Arm B |
Primary outcome
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Time frame: 1 month post partum
Both groups
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
Time frame: 1 month post partum
Both Groups
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
Time frame: 1 month post partum
Both groups
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
Time frame: 1 month post partum
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Time frame: 1 month post partum
Both groups
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Time frame: 6 months post partum
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Time frame: 6 months post partum
Both groups
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Time frame: 13 months post partum
Both groups
Infant growth as measured by "Child health card"
Time frame: 13 months post partum
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Time frame: 13 months post partum
Both groups
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
Time frame: 6 months post partum
Both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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.
Kim A Tønseth, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleft lip and palate in people with Cleft Lip and Cleft Palate, run by Oslo University Hospital at 1 site in Norway.
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 3 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: finished, as of the sponsor's last update on 23 Sep 2021. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) (time frame: 1 month post partum). The study lists 11 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 23 Sep 2021.