Follow Ups of Parents With Infants With Cleft Lip and Palate

Study Overview
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Brief Summary
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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.

Official Title
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Follow Ups of Parents With Infants With Cleft Lip and Palate

Conditions
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Cleft Lip, Cleft Palate

Intervention / Treatment
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* Other: Cleft lip and palate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm A<br>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 | |
| Active Comparator: Arm B<br>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 | Other: Cleft lip and palate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parents, Follow-Up Studies