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Dietary Supplement

Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid for Breast Milk

N/A

Waitlist Available

Led By Catherine C Cibulskis, MD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months corrected gestational age

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new additive for breast milk that provides enough protein for premature babies without causing acidity problems. It targets very small infants and aims to ensure they get the necessary nutrients for proper growth and development.

Eligible Conditions

Preterm Birth
Breast Milk

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months corrected gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months corrected gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months corrected gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Head circumference, short term

Length, short term

Weight gain, short term

Secondary study objectives

Head circumference, long term

Length, long term

Weight gain, long term

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention: HMF Hydrolyzed Protein Concentrated LiquidExperimental Treatment1 Intervention

One packet (5 mL) of Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. Feedings then continue to be advanced to full volume (160 ml/kg/d).

Group II: Standard: Liquid HMF and liquid proteinActive Control1 Intervention

This is our standard breast milk fortification in our NICU. One packet (5 mL) of Similac Human Milk Fortifier Concentrated Liquid is added to breast milk feedings when infants reach 100 ml/kg/day. A second packet is added the next day (10 mL total), to make 24 kcal/oz. After infants reach full feedings (160 ml/kg/d), 3 ml/kg of Similac Liquid Protein Fortifier is added (0.5 g/kg protein). This is increased to 6 ml/kg (1 g/kg protein) the next day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid

2017

N/A

~80

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