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NCT06893939RECRUITINGIRB Ready

Limited Versus Extended Trophic Feeding (LET-FEED) Trial

(LET-FEED)

Sponsored by University of Washington

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 350 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

\<1500 gram birthweight
25w0d-31w6d at birth
Consent to feed donor milk when parent's own milk is not available or of insufficient quantity

Exclusion Criteria

\<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 disease, etc.)
Known genetic condition affecting growth, feeding, or mortality
Vasopressor use within first 24 hours after birth (not including hydrocortisone)
Considered terminally ill

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

350 participants

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Age Range

0 Hours - 36 Hours

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Gender

ALL

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Sponsor

University of Washington

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Birmingham

Alabama

Location available
View Birmingham location page
NOT_YET_RECRUITING

Tampa

Florida

Location available
View Tampa location page
NOT_YET_RECRUITING

Oklahoma City

Oklahoma

Location available
View Oklahoma City location page
NOT_YET_RECRUITING

Houston

Texas

Location available
View Houston location page
NOT_YET_RECRUITING

Seattle

Washington

Location available
View Seattle location page
RECRUITING

Tacoma

Washington

Location available
View Tacoma location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Preterm Birth Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Preterm Birth Treatment Options in Birmingham, Alabama

If you're searching for Preterm Birth treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Tampa, Oklahoma City and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Preterm Birth. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 350 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Preterm Birth?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Preterm Birth

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Preterm Birth Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06893939. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.