Human Milk Fortifier - Growth Evaluation

May 4, 2016 updated by: Société des Produits Nestlé (SPN)

Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • CHR de la Citadelle
  • France
      • Bordeaux, France, 33000
        • Hôpital des Enfants - CHU Pellegrin
      • Caen, France, 14033
        • CHU Caen
      • Grenoble, France, 38043
        • Chu Grenoble
      • Lyon, France, 69317
        • Hôpital de la Croix-Rousse
      • Marseille, France, 13005
        • Hôpital de la Conception Marseille
      • Nancy, France, 54042
        • Maternité Régionale
      • Tours, France, 37000
        • Hôpital Clocheville Tours
  • Germany
      • Potsdam, Germany, 14467
        • Klinikum Ernest von Bergmann
  • Italy
      • Milano, Italy, 20122
        • Policlinico Mangiagalli e Regina Elena
  • Switzerland
      • Luzern, Switzerland, 6000
        • Kinderspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
  • Male or female
  • Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
  • Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
  • Written informed consent has been obtained from the legal representative(s).

Exclusion Criteria:

  • Infants with current systemic disease
  • Infants with a history of systemic disease
  • Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
  • Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
  • Infants diagnosed with any inherent metabolic disease.
  • Infants diagnosed with any chromosomic disease.
  • Receiving any commercial formula supplementation to breast milk.
  • Receiving steroids at the time of enrollment.
  • Participation in another nutritional clinical trial that may affect outcomes of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New human milk fortifier
Dietary supplement: Human milk fortifier
Active Comparator: Currently marketed fortifier
Dietary supplement: Human milk fortifier
Experimental: New human milk fortifier with new Ca source
a subgroup of patients will receive the new milk fortifier containing a new source of calcium.
Dietary supplement: Human milk fortifier

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
Time Frame: 21 days
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 8, 2013

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08.08.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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