Trial record 6 of 8 for:    Open Studies | "Cleft Lip"

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

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00993993
First received: October 13, 2009
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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).


Condition
Cleft Palate

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Assess the emotional state of withdrawal of any child carrying a CL/P based on the psychological state of their parents and time before the first surgery. We use ADBB scale for the child. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Learning about the psychological effects of this abnormality on parents from the time of diagnosis and of the therapeutic management. We use PSI scale for the parents. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Indices of psychological distress by Quebec Health Survey (IDPESQ) and the Edinburgh Postnatal Depression Scale (EPDS).The Family Impact Scale. The Dyadic Adjustment Scale Spanier of determining the marital context and questionnaires ad-hoc. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
group "early intervention"
group "late intervention"

  Eligibility

Ages Eligible for Study:   4 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care centers (France) Two referent centers Two competent centers

Criteria

Inclusion Criteria:

  • Children with Cleft Lip with or without Cleft Palate and their Parents

Exclusion Criteria:

  • Children with Cleft Palate without Cleft Lip
  • Children born the 35th week of d'amenorrhea
  • Children with a birth weight inferior to 1800 g
  • Children put under care by court order
  • Parents under administrative supervision
  • Parents who are not familiar with the french language and/or illiterate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993993

Contacts
Contact: GROLLEMUND Bruno, MD 33388365817 bruno.grollemund@libertysurf.fr

Locations
France
CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro Recruiting
Lille, France, 59037
Contact: PELLEGRIN Philippe, MD    333 20 44 54 22    malface@chru-lille.fr   
Sub-Investigator: MARTINOT DUQUESNOY Véronique, MD         
CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central Recruiting
Nancy, France, 54035
Contact: ETIENNE Simon, MD    333 83 85 12 88    e.simon@chu-nancy.fr   
Sub-Investigator: DAVROU Julien, MD         
APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale Recruiting
Paris, France, 75571
Contact: VASQUEZ Marie-Paule, MD    331 44 73 69 35    marie-paule.vazquez@trs.aphp.fr   
Sub-Investigator: SOUPRE Véronique, MD         
Sub-Investigator: GALLIANI Eva, MD         
Sub-Investigator: PICARD Arnaud, MD         
CHRU, Service de Chirurgie Infantile Recruiting
Strasbourg, France, 67098
Contact: KAUFMANN Isabelle, MD    333 88 12 73 07    isabelle.chevalier@chru-strasbourg.fr   
CSERD, Pôle d'odontologie Recruiting
Strasbourg, France, 67091
Contact: GROLLEMUND Bruno, MD    333 883 6 58 17    bruno.grollemund@libertysurf.fr   
CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1 Recruiting
Strasbourg, France, 67091
Contact: BRUANT-RODIER Catherine, MD    333 88 11 66 92    catherine.bruant-rodier@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: GROLLEMUND Bruno, MD not affiliated
  More Information

No publications provided by University Hospital, Strasbourg, France

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00993993     History of Changes
Other Study ID Numbers: 2009-A00640-57
Study First Received: October 13, 2009
Last Updated: June 28, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
cleft palate

Additional relevant MeSH terms:
Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014