Follow Ups of Parents With Infants With Cleft Lip and Palate

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02415361
• Collaborator: (none)
• Enrollment: 145
• Location: 1
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip; Cleft Palate	Other: Cleft lip and palate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 145 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Follow Ups of Parents With Infants With Cleft Lip and Palate
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Arm A 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 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; 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.

Outcome Measures

Primary Outcome Measures

1. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) [1 month post partum]

   Both groups

2. Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS) [1 month post partum]

   Both Groups

3. Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form [1 month post partum]

   Both groups

4. Infant growth as measured by "Demographic data Questionnaire" and "Child health card" [1 month post partum]

   Both groups

5. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) [1 month post partum]

   Both groups

6. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) [6 months post partum]

   Both groups

7. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) [6 months post partum]

   Both groups

8. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS) [13 months post partum]

   Both groups

9. Infant growth as measured by "Child health card" [13 months post partum]

   Both groups

10. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire) [13 months post partum]

    Both groups

11. Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire) [6 months post partum]

    Both groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo university hospital; Rikshospitalet	Oslo		Norway

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Kim A Tønseth, MD, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kim Alexander Tønseth, Head of Department of Plastic and Reconstructive Surgery, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT02415361
• Other Study ID Numbers: 2014/17828
• First Posted: Apr 14, 2015
• Last Update Posted: Sep 23, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Kim Alexander Tønseth, Head of Department of Plastic and Reconstructive Surgery, Oslo University Hospital: Parents; Follow-Up Studies
• Additional relevant MeSH terms: Cleft Palate; Cleft Lip

Study Results

No Results Posted as of Sep 23, 2021