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Comparison of Two Dose Adjustment Strategies of a Human Milk Protein Fortifier in Preterm Infants

NCT03604042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-03-06

No results posted yet for this study

Summary

The primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (PF) according to a blood urea nitrogen (BUN)-driven fortification regimen to weight gain (g/day) of infants receiving PF according to a weight-driven fortification regimen (standard of care) over a 21 day period.

Conditions

  • Weight Gain

Interventions

COMBINATION_PRODUCT

Protein fortifier

Protein Fortifier to be added to Fortified human milk according to feeding regimen

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Sebastien Paoli, Msc · Nestlé Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2020-02-10
Completion
2020-02-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604042 on ClinicalTrials.gov