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Follow Ups of Parents With Infants With Cleft Lip and Palate

Primary Purpose

Cleft Lip, Cleft Palate

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cleft lip and palate
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cleft Lip focused on measuring Parents, Follow-Up Studies

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo university hospital; Rikshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
Both Groups
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
Both groups
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Both groups
Infant growth as measured by "Child health card"
Both groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Both groups
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
Both groups

Secondary Outcome Measures

Full Information

First Posted
February 27, 2015
Last Updated
September 22, 2021
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02415361
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip, Cleft Palate
Keywords
Parents, Follow-Up Studies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
No Intervention
Arm Description
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
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cleft lip and palate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Description
Both groups
Time Frame
1 month post partum
Title
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
Description
Both Groups
Time Frame
1 month post partum
Title
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
Description
Both groups
Time Frame
1 month post partum
Title
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
Description
Both groups
Time Frame
1 month post partum
Title
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Description
Both groups
Time Frame
1 month post partum
Title
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Description
Both groups
Time Frame
6 months post partum
Title
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Description
Both groups
Time Frame
6 months post partum
Title
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
Description
Both groups
Time Frame
13 months post partum
Title
Infant growth as measured by "Child health card"
Description
Both groups
Time Frame
13 months post partum
Title
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
Description
Both groups
Time Frame
13 months post partum
Title
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
Description
Both groups
Time Frame
6 months post partum

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim A Tønseth, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo university hospital; Rikshospitalet
City
Oslo
Country
Norway

12. IPD Sharing Statement

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Follow Ups of Parents With Infants With Cleft Lip and Palate

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