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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01771588
First received: January 8, 2013
Last updated: June 30, 2014
Last verified: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771588

Locations
Belgium
CHR de la Citadelle Active, not recruiting
Liège, Belgium, 4000
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 Completed
Caen, France, 14033
CHU Grenoble Completed
Grenoble, France, 38043
Hôpital de la Croix-Rousse 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 Completed
Marseille, France, 13005
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 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 Completed
Potsdam, Germany, 14467
Italy
Policlinico Mangiagalli e Regina Elena Completed
Milano, Italy, 20122
Switzerland
Kinderspital Completed
Luzern, Switzerland, 6000
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: June 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on August 19, 2014