Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-27 @ 1:34 AM
Study NCT ID:
NCT02415361
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow Ups of Parents With Infants With Cleft Lip and Palate
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Follow Ups of Parents With Infants With Cleft Lip and Palate
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: