Clinical trial NCT05381272: Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Intra-uterine Growth Restriction
Preterm Birth
Neurodevelopmental Disorders
Placental Insufficiency
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Antenatal IUGR diagnosed preterm infants born before 34 weeks of gestational age

Brief 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.

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

Eligibility criteria: 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 (Audipog curves).

Each infant included will be matched to 2 controls on gestational age, period and sex

Exclusion Criteria:

* no

Primary outcomes:
measure: Neurodevelopmental outcomes at 2 years old evaluated by ASQ scale
timeFrame: at 2 years old
Secondary outcomes:
Other outcomes:
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Study officials:
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