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Human Milk Fortifier - Growth Evaluation

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Human milk fortifier
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth

Eligibility Criteria

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHR de la Citadelle
  • Hôpital des Enfants - CHU Pellegrin
  • CHU Caen
  • CHU Grenoble
  • Hôpital de la Croix-Rousse
  • Hôpital de la Conception Marseille
  • Maternité Régionale
  • Hôpital Clocheville Tours
  • Klinikum Ernest von Bergmann
  • Policlinico Mangiagalli e Regina Elena
  • Kinderspital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

New human milk fortifier

Currently marketed fortifier

New human milk fortifier with new Ca source

Arm Description

New human milk fortifier

Currently marketed fortifier

a subgroup of patients will receive the new milk fortifier containing a new source of calcium.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
May 4, 2016
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01771588
Brief Title
Human Milk Fortifier - Growth Evaluation
Official Title
Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New human milk fortifier
Arm Type
Experimental
Arm Description
New human milk fortifier
Arm Title
Currently marketed fortifier
Arm Type
Active Comparator
Arm Description
Currently marketed fortifier
Arm Title
New human milk fortifier with new Ca source
Arm Type
Experimental
Arm Description
a subgroup of patients will receive the new milk fortifier containing a new source of calcium.
Intervention Type
Dietary Supplement
Intervention Name(s)
Human milk fortifier
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hôpital des Enfants - CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
Hôpital de la Conception Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Maternité Régionale
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
Hôpital Clocheville Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Klinikum Ernest von Bergmann
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Policlinico Mangiagalli e Regina Elena
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Kinderspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28727654
Citation
Rigo J, Hascoet JM, Billeaud C, Picaud JC, Mosca F, Rubio A, Saliba E, Radke M, Simeoni U, Guillois B, de Halleux V, Jaeger J, Ameye L, Hays NP, Spalinger J. Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Oct;65(4):e83-e93. doi: 10.1097/MPG.0000000000001686.
Results Reference
derived

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Human Milk Fortifier - Growth Evaluation

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