Preterm BirthDNNVNCT04021654
What is the Future of Vulnerable New-borns
An observational study of Preterm Birth, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth. Read more about this study
- Who is it for?
- Ages 1 hour to 5 years
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 257 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Sep 2020
- 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 hour to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Preterm bith children
Who may be able to join
- Birth before 33 weeks of amenorrhea
- Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age.
- Perinatal anoxic-ischemia
- Other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
Who cannot join
- Children born in normal conditions.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth.
Read the detailed description
The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service), it means, newborns who are in these following risk categories:
- Birth before 33 weeks of amenorrhea
- Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age
- Perinatal anoxic-ischemia
- Other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
- A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. The data collect allow us to monitor these parameters and do a statistical study with them.
These information may be used to inform the parents about the future of the premature children cared at Pontoise. They also may be used to compare these children's future with the national data (EPIPAGE 2)
- Conditions
- Preterm Birth
- Being tested
- Data collection
- Keywords
- Preterm birth; growth; neonatology; Pregnancy; Delivery
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionProcedure or surgery
Data collection of growth, neuromotor, sensorial, behavioral, and cognitive development.
What is being measured
The primary outcome is the main question the study is designed to answer.
The pregnancy issues rate
Measure the rate of issues that occur during the pregnancy.
Measured: 2 years
Delivrey issues rate
Measurement of the rate of issues that occur during the delivery.
Measured: 2 years
% of preterm children with a failure to thrive.
Measurement of the % of children with a failure to thrive.
Measured: 2 years
Secondary outcomes (1)
Number of diseases in the children family health history.
Census of all diseases that may be in the children family health history
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 posted16 Jul 2019
- Study start1 Sep 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Miler, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021654
- Sponsor's protocol ID
- CHRD0318
- Acronym
- DNNV
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Future of Vulnerable New-borns
- ClinicalTrials.gov ID
- NCT04021654
- Acronym / sponsor ID
- DNNV / CHRD0318
- Conditions
- Preterm Birth
- Keywords
- Preterm birth; growth; neonatology; Pregnancy; Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Jul 2019 (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 aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth.
Detailed description
The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service), it means, newborns who are in these following risk categories:
- Birth before 33 weeks of amenorrhea
- Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age
- Perinatal anoxic-ischemia
- Other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
- A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. The data collect allow us to monitor these parameters and do a statistical study with them.
These information may be used to inform the parents about the future of the premature children cared at Pontoise. They also may be used to compare these children's future with the national data (EPIPAGE 2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm bith children
Key inclusion criteria (4 listed)
- Birth before 33 weeks of amenorrhea
- Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age.
- Perinatal anoxic-ischemia
- Other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
Key exclusion criteria (1 listed)
- Children born in normal conditions.
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 |
|---|---|---|
| Data collectionData collection of growth, neuromotor, sensorial, behavioral, and cognitive development. | Procedure or surgery | – |
Primary outcome
The pregnancy issues rate
Time frame: 2 years
Measure the rate of issues that occur during the pregnancy.
Delivrey issues rate
Time frame: 2 years
Measurement of the rate of issues that occur during the delivery.
% of preterm children with a failure to thrive.
Time frame: 2 years
Measurement of the % of children with a failure to thrive.
1 secondary outcome
Number of diseases in the children family health history.
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Caroline Miler principal investigator
Hôpital NOVO
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 Preterm Birth, run by Hôpital NOVO 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 1 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 19 Sep 2024. 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?
The pregnancy issues rate (time frame: 2 years). The study lists 3 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 19 Sep 2024.