Cleft PalateNCT00993993
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
An observational study of Cleft Palate, run by University Hospital, Strasbourg, France at 6 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 12 months
- Conditions the study is for
- Cleft Palate
- How many people
- 150 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Apr 2010to 7 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Primary care centers (France) Two referent centers Two competent centers
Who may be able to join
- Children with Cleft Lip with or without Cleft Palate and their Parents
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro
Lille, 59037
CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central
Nancy, 54035
APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale
Paris, 75571
CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1
Strasbourg, 67091
CSERD, Pôle d'odontologie
Strasbourg, 67091
CHRU, Service de Chirurgie Infantile
Strasbourg, 67098
About this study
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).
- Conditions
- Cleft Palate
- Keywords
- cleft palate
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group "early intervention" | Not described | |
| group "late intervention" | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study start27 Apr 2010
- Primary completion27 Apr 2010
- Study completion7 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GROLLEMUND Bruno, MD, Principal investigator, not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993993
- Sponsor's protocol ID
- 4506
- Status last verified
- Sep 2015
- First submitted
- 13 Oct 2009
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35874558Grollemund 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.
PubMed 32423402Grollemund 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.
PubMed 22682069
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00993993
- Acronym / sponsor ID
- 4506
- Conditions
- Cleft Palate
- Keywords
- cleft palate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Apr 2010 (actual)
- Primary completion
- 27 Apr 2010 (actual)
- Study completion
- 7 Jan 2013 (actual)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group "early intervention" | – | – |
| group "late intervention" | – | – |
Who may qualify
- Ages
- 4 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Primary care centers (France) Two referent centers Two competent centers
Key inclusion criteria (1 listed)
- Children with Cleft Lip with or without Cleft Palate and their Parents
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 35874558Perez 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.
- Derived from this study: PubMed 32423402Grollemund 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.
- Derived from this study: PubMed 22682069Grollemund 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.
Related trials for Cleft Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
Not yet recruiting
Furlow With Buccinator and Fistula Formation
Cleft Palate
RecruitingPhase 3
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Cleft Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GROLLEMUND Bruno, MD principal investigator
not affiliated
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate, run by University Hospital, Strasbourg, France at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00993993, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.