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

Many studies have shown that children with clefts are at high risk of
developing feeding disorders. Feeding problems can have an adverse effect on
growth, and primary protein energy malnutrition can occur. Reports describing
feeding skills in CL/P are often contradictory and lacking in detail. The soft
palate cleft is currently closed between 6 to maximum 12 months of age. No
studies have been indentified that examined the relation of surgical closure of
the cleft and the effect of this repair on feeding (difficulties).

The main objectives of this study are feeding techniques and skills and weight
gain. Secondary objectives are NS feeding *feeding sequelae*, extent of the
cleft, associated malformations, upper respiratory infections / pneumonia,
medication (child), placement of grommets (middle ear tubes), adverse
effects/complications.

Study design: Randomized controlled intervention trial

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 standard, current protocol.

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
All patient will undergo surgical intervention following the standard, current
protocol. Patients will be visited (45 minutes) by the investigator/speech
therapist at the age of 6,9,13 and 17 months. Patients will be measured
(weight) and observed following the NOL and observation lists. Parents will be
interviewed following a questionnaire and the MCH-scale. It is estimated that
the risk related to this research is negligible because; the risk of damage is
not greater than the risk of the now current care, the burden of the operation
is equal to current concerns. There is no risk of occurrence of unknown risks,
the physical burden on the child is minimal, the psychological burden for the
child and parents is minimal, there are no social risks associated with the
investigation.There are no expected risks associated with the study design and
implementation.
This research is group related. Children with CLP or CP are essential to answer
the research questions. Furthermore, children within this specific age category
(minors) are fundamental for this study since feeding is particularly important
in early childhood and children will undergo the surgical closure of the cleft
within the first year after birth.