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Completed

NCT Number: NCT02415361

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university hospital; Rikshospitalet

Oslo, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)

    Time frame: 1 month post partum

    Both groups

  2. Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)

    Time frame: 1 month post partum

    Both Groups

  3. Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form

    Time frame: 1 month post partum

    Both groups

  4. Infant growth as measured by "Demographic data Questionnaire" and "Child health card"

    Time frame: 1 month post partum

    Both groups

  5. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)

    Time frame: 1 month post partum

    Both groups

  6. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)

    Time frame: 6 months post partum

    Both groups

  7. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)

    Time frame: 6 months post partum

    Both groups

  8. Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)

    Time frame: 13 months post partum

    Both groups

  9. Infant growth as measured by "Child health card"

    Time frame: 13 months post partum

    Both groups

  10. Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)

    Time frame: 13 months post partum

    Both groups

  11. Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)

    Time frame: 6 months post partum

    Both groups

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2015
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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