Child DevelopmentDENIGRONCT03295123
Outcome of Children Born After Pregnancy Denial
An observational study of Child Development and Denial (Psychology), run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age). Read more about this study
- Who is it for?
- Ages 1 day to 8 years
- Conditions the study is for
- Child Development, Denial (Psychology), Disease
- What is being tested?
- phone interview with the mother
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2017to 31 Aug 2017
- 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 1 day to 8 years
- All sexes
- Child
Study population: Every children born at term after denial of pregnancy
Who may be able to join
- Child born after denial of pregnancy
- Child born at term ( > 37 weeks of gestation)
- Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de Nancy
Who cannot join
- Mother's opposition
- Child doesn't' living in France
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Children Born After Pregnancy Denial
The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).
The hypothesis is the denial of pregnancy may have repercussions on children's outcome.
- Being tested
- phone interview with the mother
- Medical subject headings
- Rejection, Psychology, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone interview with the motherOther
it's a telephone survey about children's health
What is being measured
The primary outcome is the main question the study is designed to answer.
height (cm)
infants height will be recorded from their health booklet and compared to reference chart log
Measured: birth
height (cm)
infants height will be recorded from their health booklet and compared to reference chart log
Measured: 9 months
height (cm)
infants height will be recorded from their health booklet and compared to reference chart log
Measured: 24 months
height (cm)
infants height will be recorded from their health booklet and compared to reference chart log
Measured: between 2 and 5 years
weight (kg)
infants weight will be recorded from their health booklet and compared to reference chart log
Measured: birth
weight (kg)
infants weight will be recorded from their health booklet and compared to reference chart log
Measured: 9 months
weight (kg)
infants weight will be recorded from their health booklet and compared to reference chart log
Measured: 24 months
weight (kg)
infants weight will be recorded from their health booklet and compared to reference chart log
Measured: between 2 and 5 years
Secondary outcomes (8)
psychomotor development
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
Measured: birth
psychomotor development
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
Measured: 9 months
psychomotor development
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
Measured: 24 months
psychomotor development
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
Measured: between 2 and 5 years
disease
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
Measured: birth
disease
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
Measured: 9 months
disease
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
Measured: 24 months
disease
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
Measured: between 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start3 May 2017
- Primary completion1 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295123
- Sponsor's protocol ID
- 2017-A00330-53
- Acronym
- DENIGRO
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2017
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Children Born After Pregnancy Denial
- ClinicalTrials.gov ID
- NCT03295123
- Acronym / sponsor ID
- DENIGRO / 2017-A00330-53
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 27 Sep 2017 (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.
The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age).
The hypothesis is the denial of pregnancy may have repercussions on children's outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- Every children born at term after denial of pregnancy
Key inclusion criteria (3 listed)
- Child born after denial of pregnancy
- Child born at term ( > 37 weeks of gestation)
- Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de Nancy
Key exclusion criteria (2 listed)
- Mother's opposition
- Child doesn't' living in France
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 |
|---|---|---|
| phone interview with the motherit's a telephone survey about children's health | Other | – |
Primary outcome
height (cm)
Time frame: birth
infants height will be recorded from their health booklet and compared to reference chart log
height (cm)
Time frame: 9 months
infants height will be recorded from their health booklet and compared to reference chart log
height (cm)
Time frame: 24 months
infants height will be recorded from their health booklet and compared to reference chart log
height (cm)
Time frame: between 2 and 5 years
infants height will be recorded from their health booklet and compared to reference chart log
weight (kg)
Time frame: birth
infants weight will be recorded from their health booklet and compared to reference chart log
weight (kg)
Time frame: 9 months
infants weight will be recorded from their health booklet and compared to reference chart log
weight (kg)
Time frame: 24 months
infants weight will be recorded from their health booklet and compared to reference chart log
weight (kg)
Time frame: between 2 and 5 years
infants weight will be recorded from their health booklet and compared to reference chart log
8 secondary outcomes
psychomotor development
Time frame: birth
psychomotor development
Time frame: 9 months
psychomotor development
Time frame: 24 months
psychomotor development
Time frame: between 2 and 5 years
disease
Time frame: birth
disease
Time frame: 9 months
disease
Time frame: 24 months
disease
Time frame: between 2 and 5 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 15 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Denial (Psychology), run by Central Hospital, Nancy, France 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 3 inclusion and 2 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 15 Feb 2023. 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?
height (cm) (time frame: birth). The study lists 8 primary outcomes in all. 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 15 Feb 2023.