Severe Intra-uterine Growth RestrictionNCT05381272
Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
An observational study of Severe Intra-uterine Growth Restriction and Preterm Birth, run by Central Hospital, Nancy, France.
Trial summary
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality. However, there is few studies on this subject, especially concerning the neurodevelopment outcomes. Read more about this study
- Who is it for?
- Ages 0 days to 2 years
- Conditions the study is for
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2022
- 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 0 days to 2 years
- All sexes
- Child
Study population: Antenatal IUGR diagnosed preterm infants born before 34 weeks of gestational age
Who may be able to join
- Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (Audipog curves).
- Each infant included will be matched to 2 controls on gestational age, period and sex
Who cannot join
- no
About this study
Official title: Impact of Severe and Very Early Onset Intra-uterine Growth Restriction on Neurodevelopemental Outcome in Preterm Infants at 2 Years Old: a Monocentric Case Control Study
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
However, there is few studies on this subject, especially concerning the neurodevelopment outcomes.
Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR.
Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.
Read the detailed description
Method: A monocentric retrospective case control study will be conducted at the Nancy University Hospital.
Each infant included (cases) will be match to 2 controls based on gestational age, period and sex which will allow us to individualize the impact of early and severe IUGR.
Inclusion criteria: Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (calculated by the Hadlok formula and reported on the CFEF curves).
Exclusion criteria: Infants with anoxo ischemic encephalopathy or major neonatal surgery.
Cases and controls have a particular follow up thanks to the "Rafael" network which is a regional perinatal network following up preterm infants and infants at risk to have impairment in neurodevelopmental outcomes.
This follow up concerns general items and items based more specifically on neurodeveloppemental outcomes.
This neurodeveloppemental follow up at 2 years old is based on the ASQ scale witch explores 5 areas : communication, gross motor, fine motor, problem solving and personal social. Thanks to this follow up we will focus on the gross motor, social and communication.
The aim of the study is to analyze the different items of the neurodevelopment between the 2 groups. The hypothesis is that premature infants with severe and early growth restriction have a delay concerning psychomotor acquisitions.
Primary outcome: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR (age of independant walking, gross motor, fine motor, communication, social items).
Secondary outcomes:
- complications during hospitalization between the 2 groups (incidence of necrotizing enterocolitis, early or late onset sepsis, retinopathy, intraventricular hemorrhage or abnormal MRI, audtion deficiency, bronchopulmonary dysplasia, persistent ductus arteriosus,...)
- neurodevelopment outcomes at 2 years of age
- growth (weight/height/CP) up to 2 years of age
- rehospitalizations during the first 2 years of life
- Conditions
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders, Placental Insufficiency
- Medical subject headings
- Premature Birth, Neurodevelopmental Disorders, Placental Insufficiency
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 |
|---|---|---|
| Cases | Infants born before 34 weeks of gestational age (WGA) with severe and early antenatal diagnosed intra uterine growth restriction | |
| Controls | infants born before 34 WGA at the same period, with no IUGR, apparied on sex and gestationnal age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale
This neurodeveloppemental follow up is based on the ASQ scale witch explores 5 areas : communication, gross motor, fine motor, problem solving and personal social.
Measured: at 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Jan 2010
- Primary completion31 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Intra-uterine Growth RestrictionStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apolline WITTWER, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381272
- Sponsor's protocol ID
- 2022PI010
- Status last verified
- May 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe and Very Early Onset Intra-uterine Growth Restriction on Neurodevelopemental Outcome in Preterm Infants at 2 Years Old: a Monocentric Case Control Study
- ClinicalTrials.gov ID
- NCT05381272
- Acronym / sponsor ID
- 2022PI010
- Conditions
- Severe Intra-uterine Growth Restriction, Preterm Birth, Neurodevelopmental Disorders, Placental Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 May 2022 (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.
Very early onset intra uterine growth restriction (IUGR) affects 5-10% of pregnancies and is the second leading cause of perinatal mortality.
However, there is few studies on this subject, especially concerning the neurodevelopment outcomes.
Objective: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR.
Hypothesis : Preterm infants with early and severe antenatal IUGR have more neurodevelopmental delay than infants with no IUGR.
Detailed description
Method: A monocentric retrospective case control study will be conducted at the Nancy University Hospital.
Each infant included (cases) will be match to 2 controls based on gestational age, period and sex which will allow us to individualize the impact of early and severe IUGR.
Inclusion criteria: Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (calculated by the Hadlok formula and reported on the CFEF curves).
Exclusion criteria: Infants with anoxo ischemic encephalopathy or major neonatal surgery.
Cases and controls have a particular follow up thanks to the "Rafael" network which is a regional perinatal network following up preterm infants and infants at risk to have impairment in neurodevelopmental outcomes.
This follow up concerns general items and items based more specifically on neurodeveloppemental outcomes.
This neurodeveloppemental follow up at 2 years old is based on the ASQ scale witch explores 5 areas : communication, gross motor, fine motor, problem solving and personal social. Thanks to this follow up we will focus on the gross motor, social and communication.
The aim of the study is to analyze the different items of the neurodevelopment between the 2 groups. The hypothesis is that premature infants with severe and early growth restriction have a delay concerning psychomotor acquisitions.
Primary outcome: to compare neurodevelopmental outcomes at the age of 2 of very preterm infants with antenatal duagnosis of severe and early IUGR in comparison with infants of the same gestational age, same sex and over the same period with no IUGR (age of independant walking, gross motor, fine motor, communication, social items).
Secondary outcomes:
- complications during hospitalization between the 2 groups (incidence of necrotizing enterocolitis, early or late onset sepsis, retinopathy, intraventricular hemorrhage or abnormal MRI, audtion deficiency, bronchopulmonary dysplasia, persistent ductus arteriosus,...)
- neurodevelopment outcomes at 2 years of age
- growth (weight/height/CP) up to 2 years of age
- rehospitalizations during the first 2 years of life
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Infants born before 34 weeks of gestational age (WGA) with severe and early antenatal diagnosed intra uterine growth restriction |
| Controls | – | –infants born before 34 WGA at the same period, with no IUGR, apparied on sex and gestationnal age |
Who may qualify
- Ages
- 0 days to 2 years
- Sex
- All
- Age groups
- Child
- Study population
- Antenatal IUGR diagnosed preterm infants born before 34 weeks of gestational age
Key inclusion criteria (2 listed)
- Infants born before 34 weeks of gestational age, and whose antenatal files were discussed at the pluridisciplinary antenatal diagnosis center of Nancy from 2010 to 2020 with diagnosis of IUGR confirmed between 22 and 25 years of age. IUGR is defined by estimated fetal weight inferior to the 3rd percentile for the gestational age (Audipog curves).
- Each infant included will be matched to 2 controls on gestational age, period and sex
Key exclusion criteria (1 listed)
- no
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
Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale
Time frame: at 2 years old
This neurodeveloppemental follow up is based on the ASQ scale witch explores 5 areas : communication, gross motor, fine motor, problem solving and personal social.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Intra-uterine Growth Restriction and Preterm Birth, run by Central Hospital, Nancy, 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 2 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: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale (time frame: at 2 years old). 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 May 2022.