Cleft Lip, Cleft Palate
Conditions
Keywords
Parents, Follow-Up Studies
Brief 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. 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.
Interventions
OTHERCleft lip and palate
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.
Sponsors
Oslo University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | 1 month post partum | Both groups |
| Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS) | 1 month post partum | Both Groups |
| Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form | 1 month post partum | Both groups |
| Infant growth as measured by Demographic data Questionnaire and Child health card | 1 month post partum | Both groups |
| Infant feeding as measured by Survey of infant diets and Feeding Questionnaire (study specific questionnaire) | 1 month post partum | Both groups |
| Infant growth as measured by Child health card | 13 months post partum | Both groups |
| Parental views on the follow up as measured by Response on the follow up (study specific questionaire) | 6 months post partum | Both groups |
Countries
Norway
Outcome results
None listed