Clinical trial NCT01771588: Human Milk Fortifier - Growth Evaluation
Official title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 186
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Bordeaux
country: France
facility: Hôpital des Enfants - CHU Pellegrin
city: Caen
country: France
facility: CHU Caen
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: Hôpital de la Conception Marseille
city: Nancy
country: France
facility: Maternité Régionale
city: Tours
country: France
facility: Hôpital Clocheville Tours
city: Potsdam
country: Germany
facility: Klinikum Ernest von Bergmann
city: Milano
country: Italy
facility: Policlinico Mangiagalli e Regina Elena
city: Luzern
country: Switzerland
facility: Kinderspital
Study officials:
References:
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.