Brief Summary

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 Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

117

participants targeted

Target at P50-P75 for all trials

Timeline

13mo left

Started Dec 2026

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

October 17, 2026

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed

1 month until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 17, 2026

Last Update Submit

October 17, 2026

Conditions

Cardiac Abnormalities Nutrient Intake

Keywords

nutritionpretermNICU admission

Outcome Measures

Primary Outcomes (1)

to investigate the association between early nutritional strategies and cardiac structure and function at 12 months of corrected age.
one year old age of preterm infants

Secondary Outcomes (1)

comparing left ventricular mass index z-scores, other echocardiographic parameters, and anthropometric outcomes among feeding groups
over one year period study