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Dietary Supplement
Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein
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
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 moreAwards & 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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Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
40,945 Total Patients Enrolled
Catherine C Cibulskis, MDPrincipal InvestigatorSt. Louis University