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Cleft Palate clinical trials

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NCT ID: NCT01252264 Completed - Cleft Palate Clinical Trials

FaceBase Biorepository

Start date: November 2010
Phase:
Study type: Observational

The purpose of this study is to find out if there are any genetic differences between people with and without disorders of the head, face, and eye. We will create a biorepository of samples from people with and without these types of birth defects. A biorepository is a collection or "bank" of human tissue materials (such as blood or saliva) for research purposes. These samples will then be available to investigators studying these disorders.

NCT ID: NCT01046591 Completed - Cleft Palate Clinical Trials

Sleep and Behavior in Children With Cleft Palate

Start date: December 2006
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether cleft palate repair increases the risk for obstructive sleep apnea in children and whether sleep apnea could explain learning and behavior difficulties that are often observed.

NCT ID: NCT00993993 Completed - Cleft Palate Clinical Trials

Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality

Start date: April 27, 2010
Phase:
Study type: Observational

The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).

NCT ID: NCT00993551 Completed - Cleft Palate Clinical Trials

Timing of Primary Surgery for Cleft Palate

TOPS
Start date: July 2010
Phase: N/A
Study type: Interventional

This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either: - Surgery at age 6 months, OR - Surgery at age 12 months. The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

NCT ID: NCT00829101 Completed - Cleft Palate Clinical Trials

Articulation and Phonology in Children With Unilateral Cleft Lip and Palate

APCLP
Start date: January 2009
Phase: N/A
Study type: Observational

The purpose of the study is to assess if there are any differences in the articulatory and phonological competence in pre-school children with unilateral cleft lip and palate (UCLP) who are treated with different surgical methods of palatal repair.

NCT ID: NCT00779961 Active, not recruiting - Cleft Palate Clinical Trials

An Investigation for the Optimal Timing of a Cleft Palate Repair

Start date: April 2008
Phase: N/A
Study type: Interventional

The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and SickKids routine palatal repair in isolated cleft palate patients.

NCT ID: NCT00773994 Completed - Cleft Palate Clinical Trials

Pilot Study Evaluating Characteristic Closure Patterns of the Normal Velopharyngeal Portal

Start date: May 2008
Phase: N/A
Study type: Interventional

This prospective research study seeks to determine how the normal velopharyngeal mechanism compares, both anatomically and physiologically, with previous data obtained on subjects with submucous cleft palate (SMCP) in IRB#07080395.

NCT ID: NCT00760006 Completed - Cleft Palates Clinical Trials

Preventing Complications in Cleft Palate Repair With Antibiotics

Start date: May 2008
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to - decrease the incidence of surgical sight infections - speed the progression of postoperative healing - improve the final quality of wound healing achieved - decrease the rate of palatal fistula formation

NCT ID: NCT00584272 Completed - Cleft Palate Clinical Trials

Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Start date: March 2007
Phase: N/A
Study type: Observational

Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.

NCT ID: NCT00423072 Completed - Cleft Palate Clinical Trials

Middle Ear Pressure Disregulation in Cleft Palate Patients

Start date: August 2006
Phase:
Study type: Observational

The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.