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Search / Trial NCT05228847

Human Milk-derived Fortification in Preterm Infants

Launched by UNIVERSITY OF CALGARY · Jan 26, 2022

Trial Information

Current as of May 07, 2025

Not yet recruiting

Keywords

Human Milk

ClinConnect Summary

This clinical trial is studying the effects of fortifying human milk for preterm infants who are born very small (weighing between 400 grams and 1250 grams). Since these tiny babies often struggle to get enough nutrition from human milk alone, the trial aims to see if adding special nutrients can help support their growth and health. The study will include infants who are born before 32 weeks of pregnancy and are expected to receive human milk for at least three weeks.

To participate in this trial, infants must meet certain conditions, such as being classified as appropriate for their gestational age and starting to receive human milk within 72 hours of birth. However, infants with serious health issues or certain maternal substance use during pregnancy will not be eligible. It's important to note that the trial is not yet recruiting participants, so families interested in this study will need to wait until it begins. The goal is to find better ways to help preterm infants grow and thrive during their crucial early weeks.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Birthweight between 400 g-1250 g
  • Less than or 32 weeks gestational age at birth
  • Subject has been classified as appropriate for gestational age
  • Enteral feeding of human milk is initiated by 72 hours
  • Subject is expected to be on human milk for at least 3 weeks.
  • Exclusion Criteria:
  • Congenital abnormalities or underlying disease that may affect growth
  • Maternal cocaine, alcohol, or opioid abuse during pregnancy
  • Mother or infant is currently receiving treatment for HIV infection
  • Infant with major surgery

About University Of Calgary

The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.

Locations

Calgary, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Belal Alshaikh, MD

Principal Investigator

University of Calgary

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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