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NCT01991613 · ClinicalTrials.gov registry record · Phase 2

Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants

A Phase 2 study of Growth in Premature Infants, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
Phase 2
Development phase
43
Enrollment target
1
Study location

NCT01991613 is a Phase 2 study of Growth in Premature Infants that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 43 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT01991613, a Phase 2 study of Growth in Premature Infants, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
Phase 2
Development phase
43 participants
Enrollment target
1
Study location

Study Summary

We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.

Interventions

  • DIETARY_SUPPLEMENT liquid protein supplement

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2013-12
Est. Completion 2015-06
Phase Phase 2

What the Registry Record Tells You About NCT01991613

The ClinicalTrials.gov registry entry for NCT01991613 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Growth in Premature Infants appearing as the primary indexed condition, and to 1 intervention - of which liquid protein supplement is the first listed.

NCT01991613 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01991613 about?

NCT01991613 is a clinical study titled "Early Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants". We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protei...

What is the current status of trial NCT01991613?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2013-12. Estimated completion is 2015-06.

What conditions does trial NCT01991613 study?

This clinical trial studies the following conditions: Growth in Premature Infants.

What interventions are being tested in trial NCT01991613?

The interventions under investigation include: liquid protein supplement (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01991613?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01991613 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.