Impact of Early and Severe Fetal Growth Restriction on Neurodevelopmental Outcomes in Preterm Infants

NCT05381272 | Unknown

• 1 other identifier: 2022PI010
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Intra-uterine Growth Restriction; Preterm Birth; Neurodevelopmental Disorders; Placental Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 0 Days - 2 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Antenatal IUGR diagnosed preterm infants born before 34 weeks of gestational age

You may qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders; Placental Insufficiency

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Placenta Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Praticien Hospitalier

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: May 19, 2022
• Study Start: January 1, 2010
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05