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Human Milk Fortifier

Study Participants for Premature Infant Diseases (MHMHMF Trial)

N/A

Waitlist Available

Research Sponsored by Northwest Health

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 daily until 36 weeks post menstrual age or discharge

Awards & highlights

MHMHMF Trial Summary

This trial is testing whether a new human milk-based fortifier helps very low birth weight infants gain weight, compared to other fortifiers.

MHMHMF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily until 36 weeks post menstrual age or discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily until 36 weeks post menstrual age or discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily 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

weight gain (gm/kg/day)

Secondary outcome measures

Head Circumference increment (cm/kg/day)

Morbidity

Volume of Fortifier

+1 more

MHMHMF Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ParticipantsExperimental Treatment1 Intervention

all preterm infants ≤ 32 weeks and 0 days gestational age (GA) with a birth weight 700 g to 1500 g at the hospital, who are enterally fed human milk in the neonatal intensive care unit (NICU) for at least 7 days. Various blending ratios of the fortifier with either the mother's expressed milk or donor milk will be used to deliver macro and micronutrients based on established guidelines to be adjusted according to the infant's tolerance for volume and calories. The estimated time for each subject's participation is approximately from 1 week through 8 weeks, depending on the weight and age at enrollment. Historic control cases treated by another human milk based human milk fortifier will be obtained from medical records, matched on birth weight and gender, with sample size twice (n=80) that of the study population.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwest HealthLead Sponsor

Neolac Inc dba Medolac LaboratoriesIndustry Sponsor

2 Previous Clinical Trials

63 Total Patients Enrolled

Sean FelsStudy DirectorMedolac Laboratories

Media Library

Medolac human milk based human milk fortifier (MHMHMF) (Human Milk Fortifier) Clinical Trial Eligibility Overview. Trial Name: NCT04478487 — N/A

Premature Infant Diseases Research Study Groups: Study Participants

Premature Infant Diseases Clinical Trial 2023: Medolac human milk based human milk fortifier (MHMHMF) Highlights & Side Effects. Trial Name: NCT04478487 — N/A

Medolac human milk based human milk fortifier (MHMHMF) (Human Milk Fortifier) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04478487 — N/A

Frequently Asked Questions

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

Are there vacant slots for volunteers in this experiment?

"Clinicaltrials.gov suggests that the trial is no longer enrolling participants, as it was initially posted on September 1st 2019 and last updated over two years ago in late 2022. However, presently there are 13 other medical trials actively recruiting patients for their clinical studies."

Answered by AI

Does my medical profile qualify me to participate in this trial?

"Eligible candidates for this clinical trial must have been born prematurely between 23 and 32 weeks gestation, in addition to having certain infant diseases. This study can accommodate up to 40 participants."

Answered by AI