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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

NCT ID: NCT00993993

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-27

Study Completion Date

2013-01-07

Brief Summary

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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).

Detailed Description

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Conditions

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Cleft Palate

Keywords

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cleft palate

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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group "early intervention"

No interventions assigned to this group

group "late intervention"

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GROLLEMUND Bruno, MD

Role: PRINCIPAL_INVESTIGATOR

not affiliated

Locations

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CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro

Lille, , France

Site Status

CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central

Nancy, , France

Site Status

APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale

Paris, , France

Site Status

CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1

Strasbourg, , France

Site Status

CSERD, Pôle d'odontologie

Strasbourg, , France

Site Status

CHRU, Service de Chirurgie Infantile

Strasbourg, , France

Site Status

Countries

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France

References

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Perez Martinez C, Grollemund B, Gavelle P, Viaux-Savelon S, Guedeney A. The Prevalence of Social Withdrawal in Infants With Cleft Lip and Palate: The Feasibility of the Full and the Modified Versions of the Alarm Distress Baby Scale. Front Pediatr. 2022 Jul 7;10:804802. doi: 10.3389/fped.2022.804802. eCollection 2022.

Reference Type DERIVED
PMID: 35874558 (View on PubMed)

Grollemund B, Dissaux C, Gavelle P, Martinez CP, Mullaert J, Alfaiate T, Guedeney A; CLIP team (Cleft Lip & palate Infant Parent). The impact of having a baby with cleft lip and palate on parents and on parent-baby relationship: the first French prospective multicentre study. BMC Pediatr. 2020 May 18;20(1):230. doi: 10.1186/s12887-020-02118-5.

Reference Type DERIVED
PMID: 32423402 (View on PubMed)

Grollemund B, Guedeney A, Vazquez MP, Picard A, Soupre V, Pellerin P, Simon E, Velten M, Dissaux C, Kauffmann I, Bruant-Rodier C, Danion-Grilliat A. Relational development in children with cleft lip and palate: influence of the waiting period prior to the first surgical intervention and parental psychological perceptions of the abnormality. BMC Pediatr. 2012 Jun 8;12:65. doi: 10.1186/1471-2431-12-65.

Reference Type DERIVED
PMID: 22682069 (View on PubMed)

Other Identifiers

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4506

Identifier Type: -

Identifier Source: org_study_id