Congenital MalformationINEMATNCT03565822
The Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation
A study testing Interview in people with Congenital Malformation, run by University Hospital, Lille at 1 site in France.
Trial summary
Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Malformation
- What is being tested?
- Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2017to 15 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- to be the parent of a child aged 12 to 36 months old having undergone neonatal surgery following oesophageal Atresia, congenital diaphragmatic hernia or short bowel syndrome diagnosis.
- to have lived with the child during his first year of life
- to have social security coverage
- to speak french
Who cannot join
- to be a person not having the capacity to consent or enjoying social protection (tutorship or guardianship);
- to be a person deprived of liberty;
- to be a minor;
- to be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative Study of the Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation on the Parental Adjustment of the First Year
Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.
- Conditions
- Congenital Malformation
- Being tested
- Interview
- Keywords
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Short Bowel Syndrome
- Medical subject headings
- Congenital Abnormalities, Esophageal Atresia, Hernias, Diaphragmatic, Congenital, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
individual interview and/or focus group Grounded theory qualitative analysis of data related to socio-demographic and child characteristics data First, data will be prepared for qualitative analysis. Digital audio files from the focus groups will be transcribed verbatim and questionnaire data will be entered into an Excel/word data file. Second, focus group data will be qualitatively analyzed using the constant comparative process. A qualitative data analysis program, NVivo11 (Victoria, Australia/ QSR International)) will be used to assist with this coding process.
| Study group | Role | What they receive |
|---|---|---|
| interview | Other | There are two data collection phases (individual interviews +/- focus groups) with parents of children with esophageal atresia, congenital diaphragmatic hernia or short bowel syndrome. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of the dynamics parental adjustment for the period from the announcement of the diagnosis to one year of the child with a rare abdominothoracic malformation requiring neonatal surgery.
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease, describing the socio-demographic characteristics of parents and children with malformation
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start15 Dec 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital MalformationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lille Nord de France
- Responsible party
- Sponsor
- Investigators
- Laurent Michaud, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565822
- Sponsor's protocol ID
- 2015_93
- Other IDs
- 2016-A02050-51
- Acronym
- INEMAT
- Status last verified
- Oct 2019
- First submitted
- 24 Apr 2018
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study of the Impact of the Birth of a Child With a Rare Abdomino-thoracic Malformation on the Parental Adjustment of the First Year
- ClinicalTrials.gov ID
- NCT03565822
- Acronym / sponsor ID
- INEMAT / 2015_93
- Conditions
- Congenital Malformation
- Keywords
- Oesophageal Atresia, Congenital Diaphragmatic Hernia, Short Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- University of Lille Nord de France
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 21 Jun 2018 (actual)
- 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.
Qualitative study in psychology whose main objective is to propose a grounded theory to report the dynamics of parental adjustment for the period from the announcement of the diagnosis to one year of the child affected by a rare thoracic abdominal congenital malformation, requiring neonatal surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interview | Other | Other: InterviewThere are two data collection phases (individual interviews +/- focus groups) with parents of children with esophageal atresia, congenital diaphragmatic hernia or short bowel syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- to be the parent of a child aged 12 to 36 months old having undergone neonatal surgery following oesophageal Atresia, congenital diaphragmatic hernia or short bowel syndrome diagnosis.
- to have lived with the child during his first year of life
- to have social security coverage
- to speak french
Key exclusion criteria (4 listed)
- to be a person not having the capacity to consent or enjoying social protection (tutorship or guardianship);
- to be a person deprived of liberty;
- to be a minor;
- to be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviewindividual interview and/or focus group Grounded theory qualitative analysis of data related to socio-demographic and child characteristics data First, data will be prepared for qualitative analysis. Digital audio files from the focus groups will be transcribed verbatim and questionnaire data will be entered into an Excel/word data file. Second, focus group data will be qualitatively analyzed using the constant comparative process. A qualitative data analysis program, NVivo11 (Victoria, Australia/ QSR International)) will be used to assist with this coding process. | Other | interview |
Primary outcome
Level of the dynamics parental adjustment for the period from the announcement of the diagnosis to one year of the child with a rare abdominothoracic malformation requiring neonatal surgery.
Time frame: at 1 year
Measure Qualitative Interviews by Grounded theory. The experience with the information received on the disease, describing the socio-demographic characteristics of parents and children with malformation
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 2 Oct 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Malformation
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Laurent Michaud, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview in people with Congenital Malformation, run by University Hospital, Lille at 1 site 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 4 inclusion and 4 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Level of the dynamics parental adjustment for the period from the announcement of the diagnosis to one year of the child with a rare abdominothoracic malformation requiring neonatal surgery. (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.