Feeding Study in VLBW Premature Infants

Stopped early · Not applicable

Conditions studied: VLBW - Very Low Birth Weight Infant

In brief

A multi-center, single-blind, randomized, controlled, parallel-designed, prospective trial to compare growth between preterm infants fed one of three study human milk fortifiers added to human milk

Key facts

Study ID

NCT05744193

Run by

Mead Johnson Nutrition

People needed

22

Starts

2023-07-10

Expected to finish

2024-05-31

Last updated by the study team

2024-07-09

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinically and metabolically stable
• Birth weight 700 g to less than or equal to 1,250 g
• Appropriate birth weight for gestational age
• 24 0/7 to 32 0/7 weeks' gestational age at birth
• Exclusively fed human milk
• Signed informed consent and authorization to use and/or disclose PHI

You may not qualify if…

• Metabolic or chronic disease
• 5-minute Apgar score <4
• Major surgery
• Ventilator dependent
• Fluid restriction
• Grade III or IV intraventricular hemorrhage (IVH)

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• Augusta University — Augusta, Georgia, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• NYU Langone Hospital, Long Island — Mineola, New York, United States
• Cohen Children's Medical Center of NY — New Hyde Park, New York, United States
• Weill Cornell Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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