CLEfts and FEeding Difficulties (CLEFED-1): the effect and timing of surgical closure in children with cleft palate.

CLEfts and FEeding Difficulties (CLEFED-1): the effect and timing of surgical closure in children with cleft palate. - CLEFED-1

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39509

Enrollment

240

Registered

2012-01-10

Start date

2012-04-12

Completion date

Unknown

Last updated

2024-05-06

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

Intervention: One group will undergo surgical closure between the age of 6-8 months and the other group between the age of 10-12 months. All patients will undergo this intervention following the sta

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Childeren born with a cleft lip and palate or cleft palate that visit the cleft team. Inclusion at the age of 5 months. Adequate understanding of the Dutch language by the parents Informed consent

Exclusion criteria

Exclusion criteria: Children that were adopted Children that are previous seen by another cleft-team (another hospital) No informed consent

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: the main study parameters of this study are: - feeding techniques and skills, defined by scores from Montreal Children*s Hospital Feeding scale (MCH), Nijmeegse Observatielijst Lepelvoeding (NOL) and an observation lists focussed on children with clefts. - weight gain (growth), defined by the difference in measurements (standard deviation) marked on a standardized growth-curve	—

Measure

Time frame

Main study parameters/endpoints: the main study parameters of this study are: - feeding techniques and skills, defined by scores from Montreal Children*s Hospital Feeding scale (MCH), Nijmeegse Observatielijst Lepelvoeding (NOL) and an observation lists focussed on children with clefts. - weight gain (growth), defined by the difference in measurements (standard deviation) marked on a standardized growth-curve

—

Secondary

Measure	Time frame
Secondary parameters/endpoints: NS 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)