Targeted fortification of donor breast milk for preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares standard fortification of donor breast milk to targeted fortification in preterm infants. The goal is to determine if targeted fortification, which measures the nutritional content of donor milk before adding fortifiers, leads to better growth outcomes compared to standard methods. By utilizing advanced technology to analyze the milk's fat, protein, and carbohydrate levels, the study aims to customize the nutritional support provided to these vulnerable infants. The hypothesis is that infants receiving targeted fortification will show improved growth metrics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Premature infants born \</= 30 weeks gestational age
* Birth Weight \</= 1500 grams

Exclusion Criteria:

* Parents do no consent to donor milk
* Confounders for poor growth such as congenital heart disease, GI diagnoses such as gastroschisis and omphalocele, and or major congenital anomalies
* Grade III or IV intraventricular hemorrhage diagnoses prior to randomization
* Small for gestational age (\<3% on Fenton Growth Curve)
* Failure to initiate fortified feeds prior to 3 weeks of life
* Diagnosis of necrotizing entercolitis prior to randomization
* Diagnosis of early onset sepsis confirmed with positive culture

Where it's running

• Columbia University Medical Center/ New York - Presbyterian
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Marianne Garland, MD — Columbia University
• Study coordinator: Marianne Garland, MD
• Email: mg71@cumc.columbia.edu
• Phone: 212 305 0952

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.