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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05381272
Other study ID # 2022PI010
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2022

Study information

Verified date May 2022
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date December 31, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A to 2 Years
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at 2 years old
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