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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | No Intervention | Standard care consists of:
| |
| Arm B | Active Comparator | Systematic follow up by a special trained nurse consists of:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleft lip and palate | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | Both groups | 1 month post partum |
| Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS) | Both Groups | 1 month post partum |
| Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form | Both groups | 1 month post partum |
| Infant growth as measured by "Demographic data Questionnaire" and "Child health card" | Both groups | 1 month post partum |
| Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 1 month post partum |
| Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) | Both groups | 6 months post partum |
| Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 6 months post partum |
| Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim A Tønseth, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo university hospital; Rikshospitalet | Oslo | Norway |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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Both groups |
| 13 months post partum |
| Infant growth as measured by "Child health card" | Both groups | 13 months post partum |
| Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) | Both groups | 13 months post partum |
| Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire) | Both groups | 6 months post partum |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |