Follow Ups of Parents With Infants With Cleft Lip and Palate

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate; Cleft Lip
• Intervention / Treatment: Other: Cleft lip and palate

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo university hospital; Rikshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)	Both groups	1 month post partum
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)	Both Groups	1 month post partum
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form	Both groups	1 month post partum
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"	Both groups	1 month post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)	Both groups	1 month post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)	Both groups	6 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)	Both groups	6 months post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)	Both groups	13 months post partum
Infant growth as measured by "Child health card"	Both groups	13 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)	Both groups	13 months post partum
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)	Both groups	6 months post partum

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Parents; Follow-Up Studies
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Cleft Palate; Cleft Lip
• Other Study ID Numbers: 2014/17828