Donor Breast Milk 2

Part of paid clinical trials in Orlando, Florida.

Sponsor
AdventHealth
Study ID
NCT07816601
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
29 Weeks - 33 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Ferrous Sulfate Oral Product — DRUG
    Dietary Supplement

Study Details

The goal of this clinical trial is to determine the serum ferritin level and hematocrit level in very preterm infants receiving donor breast milk(DBM) with an early iron supplementation protocol . The main questions it aims to answer are: Does earlier iron supplementation provide increased ferritin levels at 14 and 28 days of life in subjects fed primarily donor breast milk? Iron supplementation will be implemented when the infant achieves 80ml/kg/day of enteral feeds, as contrasted to the current protocol of full feeds (140 to 160ml/kg/day), the latter usually by Day 14 of life. At day of life(DOL) 14 (± 4 days), a blood sample will be obtained for serum ferritin determination. Similarly, a second blood draw would be performed at day of life 28 (± 4 days) or prior to discharge, whichever comes earlier

Key Dates

First listed
Sep 11, 2026
Start date
May 6, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Very preterm infants

Primary Outcome Measure

To determine the serum ferritin(ng/ml) level in very preterm infants receiving DBM with an early iron supplementation protocol. [ Time Frame: At 14 days of life(+/- 4 days) and at 28 days of life(+/- 4 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AdventHealth OrlandoOrlandoFlorida32803-

Find similar trials in Orlando, FL

By research site
AdventHealth Orlando· Orlando, FL

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