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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR3275 |
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Date of registration:
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06/02/2012 |
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Primary sponsor: |
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Public title:
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CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate.
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Scientific title:
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CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate. -
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Date of first enrolment:
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1/3/2012 |
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Target sample size:
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80 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3275 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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I.A.C.
Vries, de |
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Address:
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Division of Pediatric Plastic Surgery
Wilhelmina Children's Hospital
University Medical Center Utrecht
P.O.Box 85090
KE.04.140.0
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)88 7554004 |
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Email:
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i.a.c.devries-5@umcutrecht.nl |
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Affiliation:
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Name:
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I.A.C.
Vries, de |
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Address:
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Division of Pediatric Plastic Surgery
Wilhelmina Children's Hospital
University Medical Center Utrecht
P.O.Box 85090
KE.04.140.0
3508 AB
Utrecht
The Netherlands |
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Telephone:
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+31 (0)88 7554004 |
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Email:
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i.a.c.devries-5@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Childeren born with a cleft lip and palate or cleft palate that visit the cleft team;
2. Inclusion at the age of 5 months;
3. Adequate understanding of the Dutch language by the parents;
4. Informed consent.
Exclusion criteria: 1. Children that were adopted;
2. Children that are previous seen by another cleft-team (another hospital);
3. No informed consent.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Cleft, Cleft palate, Feeding difficulties, Surgical closure
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Intervention(s)
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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.
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Primary Outcome(s)
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1. 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;
2. Weight gain (growth), defined by the difference in measurements (standard deviation) marked on a standardized growth-curve.
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Secondary Outcome(s)
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1. NS feeding (and duration);
2. Extent of the cleft palate;
3. Associated malformations;
4. Upper respiratory infections / pneumonia;
5. Medication (child);
6. Placement of grommets (middle ear tubes);
7. Complications/adverse effects.
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Source(s) of Monetary Support
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Fonds Nuts-Ohra
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