Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

This study is currently recruiting participants.
Verified January 2014 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01771588
First received: January 8, 2013
Last updated: January 8, 2014
Last verified: January 2014
  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 Babies
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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 240
Study Start Date: April 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New human milk fortifier Dietary Supplement: Human milk fortifier
Active Comparator: Currently marketed fortifier Dietary Supplement: Human milk fortifier

  Eligibility

Ages Eligible for Study:   up to 1 Month
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771588

Locations
Belgium
CHR de la Citadelle Recruiting
Liège, Belgium, 4000
Contact: Jacques Rigo    +32 (4) 225 6322    j.rigo@ulg.ac.be   
Principal Investigator: Jacques Rigo         
France
Hôpital des Enfants - CHU Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Claude Billeaud    +33 5 56 79 56 43    claude.billeaud@chu-bordeaux.fr   
Principal Investigator: Claude Billeaud         
CHU Caen Not yet recruiting
Caen, France, 14033
Contact: Bernard Guillois, Pr    +33 (0) 2 .31.27.25.67    guillois-b@chu-caen.fr   
Principal Investigator: Bernard Guillois, Pr         
CHU Grenoble Not yet recruiting
Grenoble, France, 38043
Contact: Amandine Rubio, Dr    +33 (0) 4 76 76 87 06    arubio@chu-grenoble.fr   
Principal Investigator: Amandine Rubio, Dr         
Hôpital de la Croix-Rousse Not yet recruiting
Lyon, France, 69317
Contact: Jean-Charles Picaud, Pr    +33 (0) 4 72 00 15 50    jean-charles.picaud@chu-lyon.fr   
Principal Investigator: Jean-Charles Picaud, Pr         
Hôpital de la Conception Marseille Not yet recruiting
Marseille, France, 13005
Contact: Umberto Simeoni, Pr    +33 (0) 4 91 38 40 40    umberto.simeoni@mail.ap-hm.fr   
Principal Investigator: Umberto Simeoni, Pr         
Maternité Régionale Recruiting
Nancy, France, 54042
Contact: Jean-Michel Hascoët    +33 3 83 34 43 42    jm.hascoet@maternite.chu-nancy.fr   
Principal Investigator: Jean-Michel Hascoët         
Hôpital Clocheville Tours Not yet recruiting
Tours, France, 37000
Contact: Elie Saliba, Pr    +33 (0) 2 47 47 80 93    elie.saliba@univ-tours.fr   
Principal Investigator: Elie Saliba, Pr         
Germany
Klinikum Ernest von Bergmann Not yet recruiting
Potsdam, Germany, 14467
Contact: Michael Radke    +49 (0) 331 241 59 01    mradke@klinikumevb.de   
Principal Investigator: Michael Radke         
Italy
Policlinico Mangiagalli e Regina Elena Recruiting
Milano, Italy, 20122
Contact: Fabio Mosca    +39 02 550 32 907    fabio.mosca@unimi.it   
Principal Investigator: Fabio Mosca         
Switzerland
Kinderspital Recruiting
Luzern, Switzerland, 6000
Contact: Johannes Spalinger    +41 41 205 32 39    johannes.spalinger@luks.ch   
Principal Investigator: Johannes Spalinger         
Sponsors and Collaborators
Nestlé
  More Information

No publications provided

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: January 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on April 17, 2014