RECRUITING
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Early Routine vs. Selective Human Milk Fortification in Extremely Preterm Infants
The aim of the project is to study the effects of fortification (using a Human Milk Donor Fortifier) of an exclusive preterm human milk diet on outcome of extremely preterm neonates, born at less or equal to 27 weeks.
Conditions:
🦠 Poor Growth in Extremely Preterm Infants 🦠 Necrotizing Enterocolitis
🗓️ Study Start (Actual) 15 February 2020
🗓️ Primary Completion (Estimated) 1 January 2024
✅ Study Completion (Estimated) 1 February 2027
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Syracuse, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding

    Exclusion Criteria:

    • * Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect
Ages Eligible for Study: 0 Days to 6 Days (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 February 2020
  • First Submitted that Met QC Criteria 22 February 2020
  • First Posted 25 February 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 February 2023
  • Last Update Posted 13 February 2023
  • Last Verified February 2023
I'm interested ...!!