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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

Study Summary

This trial is testing a new human milk fortifier (HMF) to see if it is safe and effective. The new HMF has more protein than the old one, so the trial is testing to see if the new HMF, with no additional protein supplement, is as good as the old HMF plus a protein supplement.

Eligible Conditions

Premature 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

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

43,577 Total Patients Enrolled

6 Trials studying Premature Birth

2,864 Patients Enrolled for Premature Birth

Catherine C Cibulskis, MDPrincipal InvestigatorSt. Louis University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What end goal is this clinical experiment attempting to achieve?

"This trial seeks to monitor head circumference in the short-term, while weight gain, head circumfrence and length are measured over 30 days. These secondary objectives will be evaluated relative to 36 week corrected gestational age or time of hospital discharge - whichever is first."

Answered by AI

Is this medical study still admitting participants?

"As per the clinicaltrials.gov records, this specific medical trial is not presently recruiting patients. The initial posting was on March 13th 2017, with the last edit being made on May 2nd 2022. Although enrolment for this study has closed, there are still 263 trials actively searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein

Catherine Cibulskis, MD 2017. "Noninferiority Trial of Liquid Human Milk Fortifier (HMF) Hydrolyzed Protein Versus Liquid HMF With Supplemental Liquid Protein". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03001479.