Clinical trial NCT02415361: Follow Ups of Parents With Infants With Cleft Lip and Palate
Official title: Follow Ups of Parents With Infants With Cleft Lip and Palate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip
Cleft Palate
Keywords: Parents
Follow-Up Studies
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
timeFrame: 1 month post partum
measure: Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
timeFrame: 1 month post partum
measure: Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
timeFrame: 1 month post partum
measure: Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
timeFrame: 1 month post partum
measure: Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
timeFrame: 1 month post partum
measure: Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
timeFrame: 6 months post partum
measure: Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
timeFrame: 6 months post partum
measure: Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
timeFrame: 13 months post partum
measure: Infant growth as measured by "Child health card"
timeFrame: 13 months post partum
measure: Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
timeFrame: 13 months post partum
measure: Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
timeFrame: 6 months post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital; Rikshospitalet
Study officials:
affiliation: Oslo University Hospital
name: Kim A Tønseth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: