Human Milk Fortifier - Growth Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01771588
First received: January 8, 2013
Last updated: May 4, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Premature Birth
Dietary Supplement: Human milk fortifier

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Further study details as provided by Nestlé:

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. [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: April 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New human milk fortifier
New human milk fortifier
Dietary Supplement: Human milk fortifier
Active Comparator: Currently marketed fortifier
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

  Eligibility

Ages Eligible for Study:   up to 1 Month   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771588

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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01771588     History of Changes
Other Study ID Numbers: 08.08.INF 
Study First Received: January 8, 2013
Last Updated: May 4, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 24, 2016