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OpenTrials
Completed

NCT Number: NCT06843278

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants

This study compares the iron levels in very preterm infants receiving donor breast (DBM) milk to very preterm infants receiving maternal breast milk (MBM).

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Key information

Age range

2 week–4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

AdventHealth

Orlando, Florida, 32803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All preterm infants born between 29 weeks and 0 days -32 weeks and 6 days of gestational age and admitted to the NICU at Advent Health for Children
  • Received either MBM or DBM starting between 5 to10 days of life

a. Infants receiving >50% feeding volume by DBM for the first 14 days of life will be considered to have received predominantly DBM. The comparison group will be infants who received > 50% of MBM for the first 14 days of life.

  • Parent able to read and write in the English language.

Exclusion criteria

  • Death prior to completion of participation
  • Extremis with likelihood of death prior to completion of participation in the study
  • Blood transfusion as determined by clinical team during the study
  • Major congenital anomaly or genetic syndrome and
  • Major surgical GI conditions that preclude feeding

Treatment and study plan

maternal breast milk

Other

Very preterm infants receiving maternal breast milk

Donor Breast Milk

Other

Very preterm infants receiving donor breast milk

Primary outcomes

  1. The Average Serum ferritin level in very preterm infants

    Time frame: Until four weeks of age or discharge

    The average serum ferritin level (ng/ml) in very preterm infants receiving donor breast milk or maternal breast milk

Secondary outcomes

  1. The Average Hemoglobin levels (g/dl) in very preterm infants

    Time frame: Until four weeks of age or discharge

    The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk

  2. The Average Bilirubin Levels (mg/dL) in very preterm infants

    Time frame: until four weeks of age or discharge

    The average Hemoglobin levels (g/dL) in very preterm infants receiving donor breast milk or maternal breast milk

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

Donor Breast Milk and Serum Ferritin Levels in Very Preterm Infants: A Prospective, Observational Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.