Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life

StatusNot Yet Recruiting
PhaseNot specified
Started

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  1. Study First Submitted
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Preterm infants are babies born before 37 completed weeks of pregnancy. Early nutrition is important for their growth and development, and it may also be associated with how their heart develops and functions during infancy. This prospective observational study aims to investigate the association between early nutritional exposure during the neonatal period and cardiac structure and function at 12 months of corrected age in preterm infants. The study will be conducted at Assiut University Hospital and El-Eman General Hospital in Assiut, Egypt. Preterm infants born before 37 weeks of gestation who are admitted to the neonatal unit within 24 hours of birth, have adequate records of their nutritional intake, and whose parents provide written informed consent will be considered for participation. Infants with major congenital heart disease, known congenital cardiomyopathy, major genetic or chromosomal abnormalities, or other specified exclusion criteria will not be included. The study will collect information about maternal and neonatal characteristics, neonatal complications, feeding patterns, growth, and anthropometric measurements. Cardiac structure and function will be assessed using echocardiography at birth, 6 months, and approximately 12 months of corrected age. Growth measurements will also be recorded at different time points, including 12 months of corrected age. The study will compare cardiac measurements and growth outcomes among infants with different early nutritional exposures. It will also investigate which early nutritional and clinical factors are associated with left ventricular mass index at 12 months of corrected age. The findings may improve understanding of the relationship between early nutrition and cardiovascular development in preterm infants. Participation will involve clinical data collection, growth measurements, and echocardiographic assessments, with written informed consent obtained from parents or legal guardians.
Trial Details
NCT Number NCT07892209
Lead Sponsor Assiut University
Conditions
(from sponsor)
Cardiac Abnormalities, Nutrient Intake
Related terms Premature Birth
Enrollment 117 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov