|- candidate number||11092|
|- NTR Number||NTR3275|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-feb-2012|
|- Secondary IDs||11-340 METC UMCU|
|- Public Title||CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate.|
|- Scientific Title||CLEfts and FEeding Difficulties (CLEFED-1): The effect and timing of surgical closure in children with cleft palate.|
|- hypothesis||Based on the literature, clinical experience and a retrospective (pilot) study, we believe that the surgical closure of the palate positively effects feeding (difficulties) and subsequently weight gain. It is known that children with clefts are often underweight.
Moreover, it is thought that children that undergo surgery between the age of 6-8 months have better feeding skills, a better weight and less feeding difficulties at the age of 17 months, compared with children that will undergo surgery between the age of 10-12 months.
|- Healt Condition(s) or Problem(s) studied||Cleft, Cleft palate, Feeding difficulties, Surgical closure|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2012|
|- planned closingdate||1-jul-2015|
|- Target number of participants||80|
|- Interventions||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.|
|- Primary outcome||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.
|- Secondary outcome||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.
|- Timepoints||6, 9, 13 and 17 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. I.A.C. Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. I.A.C. Vries, de|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Craniofacial anomalies are an important category of congenital defects, due to the high rate of morbidity, relatively high incidence, and their evident adverse effects on health and social development. Cleft lip and/or palate (CL/P) are the most common form of craniofacial defects and may occur isolated or in association with other anomalies. These defects arise in about 1-2 per 1.000 live born babies. Many 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.
The majority of the research literature on feeding difficulties, interventions and parents support is based on retrospective, non-randomized controlled studies, expert opinion or non-systematic review articles.
Futhermore there is a large discrepancy in the literature about the best time of closure for the hard palate. In our unit, like in most units in the world the hard palate is closed before 12 months of age. The influence that surgical closure time has on the feeding problems has never been investigated.
The purpose of this study is to investigate the effect of the surgical closure on feeding (difficulties) and if there is a difference between an early (age 6-8 months) and late (age 10-12 months) surgical closure of the cleft.
Our evidence based results can help clinicians, involved in the care of CP patients, in providing proper information and professional support, concerning CLP and the approach and treatment of feeding disorders.
Clinically it is important that clinicians are able to give answers to questions that are based on solid scientifically evidence. It is important to determine the best timing for surgical closure because of the effect on feeding (difficulties). This could be important for the general well being of the patient but also financially for the health care system.
|- Main changes (audit trail)|
|- RECORD||6-feb-2012 - 2-mrt-2012|