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van CCT (UK)

van CCT (UK)

How much and which feeding difficulties do we see in children with cleft lip and/or palate?

- candidate number17722
- NTR NumberNTR4592
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-mei-2014
- Secondary IDs14-149/M METC
- Public TitleHow much and which feeding difficulties do we see in children with cleft lip and/or palate?
- Scientific TitleCLEfts and FEeding Difficulties (CLEFED-2) The prevalence of feeding difficulties in children with cleft lip and/or palate.
- hypothesisMany studies have shown that children with clefts are at high risk of developing feeding disorders. Especially children with a cleft lip and palate (CLP) or cleft palate only (CP) are subject to feeding disorders. 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
- Healt Condition(s) or Problem(s) studiedCleft palate, Feeding difficulties, Parent-child interaction
- Inclusion criteriaConsecutive 70 children with a cleft (age 0-4 weeks) that visit the cleft-team:
- adequate understanding of the Dutch language by the parents
- (expressed (gekolfde)) breast and bottle feeding
- cleft lip
- cleft lip and palate - cleft palate only
- Informed consent 
- Exclusion criteriaPatients cannot participate in this study if they meet one or more of the following criteria:
- previous treatment and follow-up by another cleft-team (another hospital)
- no informed consent
- children that were adopted
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-jun-2014
- planned closingdate9-apr-2017
- Target number of participants70
- InterventionsNone
- Primary outcomeFeeding problems (techniques and skills)
Birth weight and weight gain
Parent-child interaction
- Secondary outcome- NG feeding incidence (and duration)
• ‘Feeding sequelae’ (gagging, choking, apnea’s , regurgitation)
• Extent of the cleft
• Associated malformations
• Breathing problems
• Upper respiratory infections / pneumonia
• Medication (child)
• Surgical closure of the lip
• Adverse effects/complications
- TimepointsObservation of feeding at 4 weeks, 3 months and 6 months of age.
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- Publications
- Brief summarySUMMARY
Rationale: Many studies have shown that children with clefts are at high risk of developing feeding disorders. Early nutritional deficits are linked to long-term impairment in growth, health and development of children. There is no consensus about the prevalence of feeding difficulties in children with clefts. Furthermore, too little is known about the birth weight and growth of children with clefts in comparison to their healthy peers. Objective: The main objectives of this study are (1) what is the nature and course of nutritional problems in children with cleft lip and palate receiving cleft care following the standard protocol in the Wilhelmina Childrens Hospital, Utrecht, The Netherlands? (2) are children with clefts significantly more underweight then healthy children between 0 and 6 months of age? (3) is there a difference in the parent-child interaction in comparison to healthy children? Secondary objectives are nasogastric (NG) feeding, ‘feeding sequelae’, extent of the cleft, associated malformations, breathing problems, upper respiratory infections / pneumonia, medication (child), surgical closure of the lip, adverse effects/complications.
Study design: longitudinal prospective descriptive study
Study population: Consecutive 70 children (age 0-6 months) born with cleft lip (CL) cleft lip and palate (CLP) or cleft palate only (CP), seen at the cleft-team of the Wilhelmina Children's Hospital in Utrecht, The Netherlands.
Intervention: there will be no use of an investigational treatment.
Main study parameters/endpoints: The main study parameter is feeding technique and skills, most importantly defined by the ‘Nijmeegse Observatielijst Lepelvoeding’ (NOL), ‘Schedule from Oral-Motor Assessment’ (SOMA) and the observation list feeding skills. In addition weight gain (growth), is studied, and defined by the difference in measurements (standard deviation) marked on a standardized growth-curve. The parent-child interaction is defined by the observation-list parent-child interaction.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be seen (during 45 minutes) by the investigator and speech therapist at the age of 4 weeks, 3 and 6 months at home. Patients will be measured (weight) (and the parents will be interviewed) and will be observed. It is estimated that the risk related to this research is negligible because the risk of complications is not greater than the risk of the current care. There is no risk of occurrence of unknown risks. The physical and psychological burden for the child and parents is minimal and there are no social risks associated with the investigation. Furthermore 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.
- Main changes (audit trail)
- RECORD23-mei-2014 - 10-jun-2014

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