Neonatal outcome of small for gestational age preterm infants.
Stefano Nobile, Paolo Marchionni, Virgilio P Carnielli
https://pubmed.ncbi.nlm.nih.gov/28660312Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-26
54
Participants Needed
1
Research Sites
N/A
Total Duration
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
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Fondazione Policlinico Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
S
Stefano Nobile, MD, PhD, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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