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Dietary Supplement

Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid for Premature Birth

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

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
  • Premature Birth
  • Breast Milk

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Head circumference, short term
Length, short term
Weight gain, short term
Secondary outcome measures
Head circumference, long term
Length, long term
Weight gain, long term
+2 more

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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Who is running the clinical trial?

St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,568 Total Patients Enrolled
5 Trials studying Premature Birth
1,664 Patients Enrolled for Premature Birth
Catherine C Cibulskis, MDPrincipal InvestigatorSt. Louis University
~9 spots leftby Sep 2025
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