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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 is a NA study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 300 participants.

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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 Registry Record Tells You About NCT00005888

The ClinicalTrials.gov registry entry for NCT00005888 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.

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

NCT00005888 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.