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Compares treatment options for Sepsis
Official title Limited Versus Extended Trophic Feeding (LET-FEED) Trial
ClinicalTrials.gov ID: NCT06893939
What this study is testing
- What it's testing
- Study Hypothesis/Question In infants born very preterm, advancing enteral feeds after 24 hours from birth (limited trophic feeds) versus after 72 hours (extended trophic feeds) reduces the risk of all-cause late onset sepsis (LOS) without increasing the risk of other adverse outcomes. Study Design Type This is a multi-center, open-label, parallel-group, individual randomized controlled trial comparing two different trophic feeding regimens in preterm infants born between 25w0d and 31w6d.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 36. Healthy volunteers may be eligible.
You may be able to join if
- \<1500 gram birthweight
- 25w0d-31w6d at birth
- Consent to feed donor milk when parent's own milk is not available or of insufficient quantity
You likely can't join if
- \<5th percentile for weight at birth (Fenton growth curve)
- Parent or legal guardian unable to provide consent within 36 hours after birth
- Congenital anomaly affecting decisions on enteral feedings (e.g. gastroschisis, omphalocele, congenital diaphragmatic hernia, congenital heart...
- Known genetic condition affecting growth, feeding, or mortality
- Vasopressor use within first 24 hours after birth (not including hydrocortisone)
- Considered terminally ill
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tampa, Florida, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Tacoma, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 hours to 36 hours. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tampa, Florida, United States; Oklahoma City, Oklahoma, United States; Houston, Texas, United States; Seattle, Washington, United States; Tacoma, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.