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Human Milk Fortifier

Prospective for Premature Infants (MedolacHMF Trial)

N/A
Waitlist Available
Led By Amy Gates, RD
Research Sponsored by Augusta 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 every 14 days until 36 weeks post menstrual age or discharge
Awards & highlights

MedolacHMF Trial Summary

The purpose of this two-arm investigation is to determine if growth patterns of very low birth weight infants (VLBW) (birth weight 750-1500 grams) fed human milk (maternal or donor) supplemented with a human milk-based fortifier grow according to established guidelines and maintain adequate micronutrient levels.

Eligible Conditions
  • Premature Infants
  • Breastfeeding

MedolacHMF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 14 days until 36 weeks post menstrual age or discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 14 days until 36 weeks post menstrual age or discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Growth Velocity
Mean Serum CO2
Mean Serum Magnesium
+1 more
Secondary outcome measures
Mean serum Alkaline Phosphatase
Mean serum Blood Urea Nitrogen (BUN)
Mean serum Calcium
+8 more

MedolacHMF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ProspectiveExperimental Treatment1 Intervention
All neonates with birth weights ranging from 750-1500 grams and gestational ages 23-33 weeks admitted to the NICU at Augusta University within 24 hours of life will be eligible for screening within 72 hours of admission and upon parent's or legal guardian's consent. Infants will be fed a human milk fortifier made with donor human milk. Data will be compared with historic control data.
Group II: Retrospective Chart ReviewActive Control1 Intervention
Retrospective Chart Review for historical controls. Historic controls fed cow's milk fortifier

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
211 Previous Clinical Trials
85,017 Total Patients Enrolled
Neolac Inc dba Medolac LaboratoriesIndustry Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
Amy Gates, RDPrincipal InvestigatorAugusta University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Journal of PediatricsJournal
Randomized Trial of Exclusive Human Milk Versus Preterm Formula Diets in Extremely Premature Infants
Cristofalo, Elizabeth A., Richard J. Schanler, Cynthia L. Blanco, Sandra Sullivan, Rudolf Trawoeger, Ursula Kiechl-Kohlendorfer, Golde Dudell, et al.. 2013. “Randomized Trial of Exclusive Human Milk Versus Preterm Formula Diets in Extremely Premature Infants”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2013.07.011.
Journal of Pediatric Gastroenterology & NutritionJournal
Enteral Nutrient Supply for Preterm Infants: Commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition
Agostoni, C, G Buonocore, VP Carnielli, M De Curtis, D Darmaun, T Decsi, M Domellöf, et al.. 2010. “Enteral Nutrient Supply for Preterm Infants: Commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition”. Journal of Pediatric Gastroenterology & Nutrition. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpg.0b013e3181adaee0.
PediatricsJournal
Breastfeeding and the Use of Human Milk
SECTION ON BREASTFEEDING, Arthur I. Eidelman, Richard J. Schanler, Margreete Johnston, Susan Landers, Larry Noble, Kinga Szucs, and Laura Viehmann. 2012. “Breastfeeding and the Use of Human Milk”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2011-3552.
PediatricsJournal
Neonatal Outcomes of Extremely Preterm Infants from the NICHD Neonatal Research Network
Stoll, Barbara J., Nellie I. Hansen, Edward F. Bell, Seetha Shankaran, Abbot R. Laptook, Michele C. Walsh, Ellen C. Hale, et al.. 2010. “Neonatal Outcomes of Extremely Preterm Infants from the NICHD Neonatal Research Network”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2009-2959.
~9 spots leftby Apr 2025
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