The purpose of this study is to contribute to the knowledge of feeding problems in infants with CL, CP and CLP. Our evidence based results can help clinicians, involved in the care of cleft patients, in providing proper information and professional…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
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 generally closed between 6 to maximum 12 months of age. There
is no consensus about the exact prevalence of feeding difficulties and the
relation of birthweight and growth with clefts.
Study objective
The purpose of this study is to contribute to the knowledge of feeding problems
in infants with CL, CP and CLP. Our evidence based results can help clinicians,
involved in the care of cleft patients, in providing proper information and
professional support and the approach and treatment of feeding disorders; (1)
it will give information about the prevalence of feeding difficulties in
children with clefts which of course is essential as a starting point in
approving adequate professional counseling; e.g. how many children with clefts
are subject to feeding disorders? and is there a difference between the
different types of clefts? (2) Furthermore this study will prospectively
investigate the birth weight and growth of children with clefts in comparison
to children without clefts. If seems important to know how the nutritional
status of children with clefts is directly after birth and how it develops in
the months after. (3) Finally, the parent-child interaction is investigated and
related to the interaction of parents and their healty children. This
information will significantly contribute to the determination of adequate
therapeutic strategies.
Our aim is to do a longitudinal prospective trail. The study population
consists of children born with a cleft.
Study design
Prospective longitudinal observational trial
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: *
Patients will visit (45 minutes) the investigator and speech therapist at the
age of 4 weeks, 3 and 6 months. Patients will be measured (weight) and observed
following the NOL and observation lists. Parents will be interviewed following
a questionnaire. 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. 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 CL, 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 growth is observed in
early life.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
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
- previous treatment and follow-up by another cleft-team (another hospital)
- no informed consent
- children that were adopted
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48107.041.14 |