NCT01771588

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

January 8, 2013

Last Update Submit

May 4, 2016

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

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

    21 days

Study Arms (3)

New human milk fortifier

EXPERIMENTAL

New human milk fortifier

Dietary Supplement: Human milk fortifier

Currently marketed fortifier

ACTIVE COMPARATOR

Currently marketed fortifier

Dietary Supplement: Human milk fortifier

New human milk fortifier with new Ca source

EXPERIMENTAL

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

Dietary Supplement: Human milk fortifier

Interventions

Human milk fortifierDIETARY_SUPPLEMENT
Currently marketed fortifierNew human milk fortifierNew human milk fortifier with new Ca source

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHR de la Citadelle

Liège, 4000, Belgium

Location

Hôpital des Enfants - CHU Pellegrin

Bordeaux, 33000, France

Location

CHU Caen

Caen, 14033, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Hôpital de la Croix-Rousse

Lyon, 69317, France

Location

Hôpital de la Conception Marseille

Marseille, 13005, France

Location

Maternité Régionale

Nancy, 54042, France

Location

Hôpital Clocheville Tours

Tours, 37000, France

Location

Klinikum Ernest von Bergmann

Potsdam, 14467, Germany

Location

Policlinico Mangiagalli e Regina Elena

Milan, 20122, Italy

Location

Kinderspital

Lucerne, 6000, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 28727654DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 18, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

BE(1)DE(1)IT(1)CH(1)FR(7)