deltatrials
Active Not Recruiting NA INTERVENTIONAL 2-arm NCT04325308

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Updated 15 times since 2020 Last updated: Sep 11, 2025 Started: Aug 13, 2020 Primary completion: Jan 2, 2023 Completion: Sep 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Breast Milk Expression and Feeding Disorder Neonatal, this trial is ongoing. The trial is conducted by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has accumulated 15 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Aug 2020 · 3 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshot~Jun 2022 – ~Feb 2023 · 8 months · monthly snapshot~Feb 2023 – ~Nov 2023 · 9 months · monthly snapshot~Nov 2023 – ~Apr 2024 · 5 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

15 versions recorded
  1. Oct 2025 — Present [monthly]

    Active Not Recruiting NA

  2. Sep 2025 — Oct 2025 [monthly]

    Active Not Recruiting NA

  3. Apr 2025 — Sep 2025 [monthly]

    Active Not Recruiting NA

  4. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting NA

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

Show 10 earlier versions
  1. Apr 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

  2. Nov 2023 — Apr 2024 [monthly]

    Active Not Recruiting NA

  3. Feb 2023 — Nov 2023 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  4. Jun 2022 — Feb 2023 [monthly]

    Recruiting NA

  5. Sep 2021 — Jun 2022 [monthly]

    Recruiting NA

  6. Jan 2021 — Sep 2021 [monthly]

    Recruiting NA

  7. Sep 2020 — Jan 2021 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  8. Aug 2020 — Sep 2020 [monthly]

    Not Yet Recruiting NA

  9. May 2020 — Aug 2020 [monthly]

    Not Yet Recruiting NA

  10. Apr 2020 — May 2020 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Alabama at Birmingham
Data source: University of Alabama at Birmingham

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations