Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants

Launched by CROUSE HOSPITAL · Feb 22, 2020

Keywords

ClinConnect Summary

**Trial Summary: Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants**

This clinical trial is investigating how different methods of adding nutrients to human milk can help extremely preterm babies grow and stay healthy. Specifically, it looks at whether starting to fortify breast milk early—right after the baby is born—makes a difference compared to waiting to add the fortifier until later. The study focuses on infants born at or before 27 weeks of pregnancy, who are at risk for poor growth and other serious conditions.

To participate in this trial, infants must be extremely preterm and admitted to the neonatal intensive care unit (NICU) within the first week of life. Unfortunately, babies with significant congenital issues, such as certain heart problems or genetic disorders, cannot be included. If you are eligible and choose to participate, you can expect to be part of a study that aims to improve the health outcomes of the smallest and most vulnerable newborns. Your baby's growth and health will be closely monitored throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding
• Exclusion Criteria:
• • Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect