ELFIGOLung Function in Infants with Intrauterine Growth Restriction
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+9
+ Female Urogenital Diseases and Pregnancy Complications
+ Fetal Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: April 20, 2025
Actual date on which the first participant was enrolled.This study focuses on babies who are smaller or grow less than expected during pregnancy, a condition known as fetal growth restriction (FGR). FGR is diagnosed by ultrasound and can lead to short- and long-term respiratory problems, especially when diagnosed before 32 weeks of pregnancy. The study aims to understand the link between certain parameters assessed during pregnancy, such as lung volumes, diaphragm thickness, and cardiac kinetics, and any respiratory complications in the first years of life. The study involves two groups: fetuses and preterm infants with a history of FGR, and preterm infants without a history of FGR. The study is important as it could help improve care and address challenges related to FGR and respiratory issues in preterm infants. Pregnant women with fetuses diagnosed with FGR are monitored closely, with weekly ultrasounds and other tests to check fetal well-being. After birth, the child's respiratory function is assessed during hospitalization and in subsequent outpatient visits. These assessments include respiratory function tests at 3, 6, 12, and 24 months of corrected age. The study also collects routine clinical data from the child's medical record. For preterm infants without FGR, similar data is collected after obtaining informed consent. The study measures outcomes such as the need for respiratory support at 36 weeks post-menstrual age, occurrence of death during NICU admission or afterwards, and lung function data from certain tests.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fondazione Policlinico Gemelli IRCCS
Roma, ItalyOpen Fondazione Policlinico Gemelli IRCCS in Google Maps