Follow Ups of Parents With Infants With Cleft Lip and Palate

NCT ID: NCT02415361

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Cleft lip and palate

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kim Alexander Tønseth

Head of Department of Plastic and Reconstructive Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim A Tønseth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo university hospital; Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

2014/17828

Identifier Type: -

Identifier Source: org_study_id