Human Milk Fortifier - Growth Evaluation

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Dietary Supplement: Human milk fortifier

• Registration Number: NCT01771588
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2013-01-08
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
New human milk fortifier	Human milk fortifier	New human milk fortifier
New human milk fortifier with new Ca source	Human milk fortifier	a subgroup of patients will receive the new milk fortifier containing a new source of calcium.
Currently marketed fortifier	Human milk fortifier	Currently marketed fortifier

Primary Outcome Measures

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

Trial Locations

Locations (11)

CHR de la Citadelle; 🇧🇪 Liège, Belgium

Hôpital Clocheville Tours; 🇫🇷 Tours, France

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France

Klinikum Ernest von Bergmann; 🇩🇪 Potsdam, Germany

CHU Grenoble; 🇫🇷 Grenoble, France

Maternité Régionale; 🇫🇷 Nancy, France

Hôpital des Enfants - CHU Pellegrin; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

Hôpital de la Conception Marseille; 🇫🇷 Marseille, France

Policlinico Mangiagalli e Regina Elena; 🇮🇹 Milano, Italy

Kinderspital; 🇨🇭 Luzern, Switzerland