Follow Ups of Parents With Infants With Cleft Lip and Palate

University of Oslo (UIO)

Status: Completed

Conditions: Cleft Palate; Cleft Lip

Treatments: Other: Cleft lip and palate

Study type: Interventional

Funder types: Other

Identifiers

NCT02415361

2014/17828

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Arm A

No Intervention group

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 B

Active Comparator group

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

Treatment:

Other: Cleft lip and palate