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NCT00005888 · ClinicalTrials.gov registry record · NA

Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants

A NA study, sponsored by National Center for Research Resources (NCRR).

Completed
Registry status
NA
Development phase
300
Enrollment target

NCT00005888: Completed NA study, sponsored by National Center for Research Resources (NCRR).

NCT00005888 is a NA study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00005888, a NA study, has completed, sponsored by National Center for Research Resources (NCRR).

COMPLETED
Registry status
NA
Development phase
300 participants
Enrollment target

Study Summary

OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified pasteurized donor human milk or preterm formula, and with fortified mother's milk versus preterm formula. II. Determine the relationship between functional antibody titers in serial milk samples and the incidence of pathogen specific late onset sepsis (e.g., Staphylococcus epidermidis, Staphylococcus aureus) in these patients. III. Determine the long term sequelae (growth, body composition, health, and neurodevelopment) of human milk versus formula feeding in these patients. IV. Determine the relationship between stress and milk production in the mothers of these patients.

Interventions

  • BEHAVIORAL Fortified Pasteurized Donor Human Milk supplement
  • BEHAVIORAL Preterm Formula supplement

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 1997-01
Phase NA

What the finished NCT00005888 record still lists

NCT00005888 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Fortified Pasteurized Donor Human Milk supplement is the first listed.

NCT00005888 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00005888 about?

NCT00005888 is a clinical study titled "Study of the Relationship Between Feeding and Late Onset Sepsis and/or Necrotizing Enterocolitis in Low Birth Weight Infants". OBJECTIVES: I. Compare the incidence of late onset sepsis and/or necrotizing enterocolitis and duration of hospitalization in low birth weight infants fed with fortified mother's milk supplemented with either fortified pasteurized donor human milk or preterm formula, and with fortified mother's milk...

What is the current status of trial NCT00005888?

This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 1997-01.

What interventions are being tested in trial NCT00005888?

The interventions under investigation include: Fortified Pasteurized Donor Human Milk supplement (BEHAVIORAL), Preterm Formula supplement (BEHAVIORAL).

Who is sponsoring clinical trial NCT00005888?

This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00005888's enrollment target sits among peer trials

300 330th of 2000 higher than 1,630 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00005888, the US trial registry maintained by the National Library of Medicine. NCT00005888 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.