Follow Ups of Parents With Infants With Cleft Lip and Palate

NCT02415361 | Completed

• 1 other identifier: 2014/17828
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip; Cleft Palate

Keywords

Parents; Follow-Up Studies

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Arm A

NO INTERVENTION

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 B

ACTIVE COMPARATOR

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

Interventions

Cleft lip and palate OTHER

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.

Arm B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo university hospital; Rikshospitalet

Oslo, Norway

Location

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• Kim A Tønseth, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Plastic and Reconstructive Surgery

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: April 14, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 23, 2021

Record last verified: 2021-09

Locations

NO (1)