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CLEfts and FEeding Difficulties (CLEFED-2) The prevalence of feeding difficulties in children with cleft lip and/or palate.

CLEfts and FEeding Difficulties (CLEFED-2) The prevalence of feeding difficulties in children with cleft lip and/or palate. - CLEfts and FEeding Difficulties (CLEFED-2)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41195
Enrollment
70
Registered
2014-05-06
Start date
2014-07-17
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cleft lip cleft palate

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Consecutive 70 children (age 0-4 weeks) that visit the cleft-team: - adequate understanding of the Dutch language by the parents - cleft lip - cleft lip and palate - cleft palate only - Informed consent

Exclusion criteria

Exclusion criteria: - previous treatment and follow-up by another cleft-team (another hospital) - no informed consent - children that were adopted

Design outcomes

Primary

MeasureTime frame
the main study parameters of this study are:* - feeding techniques and skills, defined by the Nijmeegse Observatielijst Lepelvoeding (NOL) and SOMA and an observation lists focussed on children with clefts and parent-child interaction. - weight gain (growth), defined by the difference in measurements (standard deviation) marked on a standardized growth-curve

Secondary

MeasureTime frame
NG feeding (and duration), extent of the cleft palate, associated malformations, upper respiratory infections / pneumonia, medication (child), placement of grommets (middle ear tubes), complications/adverse effects

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)