Actively Recruiting

All Genders
ID06919757

Early Lung Function Trajectories: Comparison Between Infants With Intrauterine Growth Restriction and Appropriately Grown Ones

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-26

54

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on babies born prematurely before 32 weeks of gestation, some of whom have fetal growth restriction (FGR), a condition where babies grow less than expected in the womb. The study aims to explore how measurements taken during pregnancy, such as lung size, diaphragm strength, and heart function detected through ultrasound, relate to breathing problems and other complications in early life. It compares infants with a history of FGR to those without, to better understand early lung function trajectories in these groups. Participants include two groups: preterm infants with a prenatal history of FGR and preterm infants without such history. Pregnant women with suspected FGR receive weekly ultrasounds including Doppler studies of blood flow and weight estimates every two weeks, along with heart rate monitoring once or twice weekly. After birth, infants undergo respiratory assessments and lung function tests at set intervals during the first two years of life, with clinical data collected routinely. During the study, researchers monitor infants’ respiratory health through hospital and outpatient visits at 3, 6, 12, and 24 months of corrected age, performing at least two lung function tests over that period. Other routine clinical information is also gathered from medical records. The main outcomes measured include bronchopulmonary dysplasia at 36 weeks post-menstrual age, survival by two years, and lung function data at two years. Secondary measures include oxygen saturation ratios at 16 weeks of life.

CONDITIONS

Brief Title

Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Fetuses and infants born before 32 weeks of gestation, with or without fetal growth restriction
Not Eligible

You will not qualify if you...

  • Lack of informed consent
  • Need for palliative care
  • Major malformations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - During pregnancy until birth

Participants undergo fetal ultrasound assessments to evaluate lung volumes, diaphragmatic thickness and contractility, and cardiac parameters before birth.

1 to 2 visits depending on fetal assessments

Long-term Monitoring

Duration - Up to 2 years of life

Participants are monitored for respiratory function and complications through the first two years of life, including lung function tests and oxygen saturation measurements.

Periodic visits for lung function tests and oxygen saturation measurements

Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

Loading map...

Research Team

S

Stefano Nobile, MD, PhD, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

Similar Trials

Acoustics as a Metric of Airway Pressure in Premature Infant...

Preterm Infant

Actively Recruiting

1 location

Comparison of Air vs. Cutaneous Control Mode for Preterm Inf...

Preterm Infant

Actively Recruiting

1 location

Clinical Impact of Non-invasive Neurally Adjusted Ventilator...

Preterm Infant

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Oxygen saturation/FIO2 ratio at 36 weeks' PMA in 1005 preterm infants: Effect of gestational age and early respiratory disease patterns.

Stefano Nobile, Paolo Marchionni, Carlo Gidiucci...

https://pubmed.ncbi.nlm.nih.gov/30688034