Follow Ups of Parents With Infants With Cleft Lip and Palate

Cleft Palate Clinical Trial

Official title:

Follow Ups of Parents With Infants With Cleft Lip and Palate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415361
• Other study ID #: 2014/17828
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2019

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate

Intervention

Other:
• Cleft 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.

Locations

Country	Name	City	State
Norway	Oslo university hospital; Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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