Cleft Palate Clinical Trial
Official title:
Follow Ups of Parents With Infants With Cleft Lip and Palate
NCT number | NCT02415361 |
Other study ID # | 2014/17828 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | January 2019 |
Verified date | September 2021 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo university hospital; Rikshospitalet | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | Both groups | 1 month post partum | |
Primary | Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS) | Both Groups | 1 month post partum | |
Primary | Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form | Both groups | 1 month post partum | |
Primary | Infant growth as measured by "Demographic data Questionnaire" and "Child health card" | Both groups | 1 month post partum | |
Primary | Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 1 month post partum | |
Primary | Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | Both groups | 6 months post partum | |
Primary | Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 6 months post partum | |
Primary | Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | Both groups | 13 months post partum | |
Primary | Infant growth as measured by "Child health card" | Both groups | 13 months post partum | |
Primary | Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 13 months post partum | |
Primary | Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire) | Both groups | 6 months post partum |
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