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Probiotics Supplementation in Premature Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379417
First Posted: June 23, 2011
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
The main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. As secondary objectives, different parameters related to probiotics tolerance will be measured.

Condition Intervention
Prematurity Dietary Supplement: Probiotic supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Probiotics Supplementation and Nutritional Benefit in Premature Infants

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Weight (g) [ Time Frame: From 4 to 6 weeks after inclusion ]

Secondary Outcome Measures:
  • Growth [ Time Frame: between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period) ]

    measured by:

    • weight gain (g/day)
    • height (cm/week)
    • head circumference(cm/week)


Enrollment: 199
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Maltodextrin
Maltodextrin
Dietary Supplement: Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Active Comparator: Probiotic B lactis/B longum
Bifidobacterium lactis + Bifidobacterium longum
Dietary Supplement: Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Active Comparator: Probiotic B longum
Bifidobacterium longum
Dietary Supplement: Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
Active Comparator: Probiotic B lactis
Bifidobacterium lactis
Dietary Supplement: Probiotic supplementation
1 capsule per day, from inclusion to 4 or 6 weeks after inclusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Gestational age between 26 weeks and 31 weeks
  • Birth weight between 700 to 1600 g
  • Eutrophic infants (weight between -2 to 2 DS, Usher curves)
  • Admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life.
  • Still on parenteral feeding or infusion on the 5th day of birth

Non inclusion criteria

  • Digestive disorders > or equal to 1b on Bell stage
  • Severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life.
  • Severe malformations or digestive malformations
  • No antenatal corticosteroid therapy
  • Severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (Hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis).
  • Parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age)

Exclusion criteria

  • Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (> or equal to 2a on Bell stage )
  • Serious digestive surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379417


Locations
France
Service de Nénatologie, Hôpital Femme Mère Enfant
Bron, France, 69678
Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse
Lyon, France, 69317
Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Jean-Charles Picaud, Pr Hôpital de la Croix-Rousse
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01379417     History of Changes
Other Study ID Numbers: 04.01.FR.INF
2006-A00062-49 ( Other Identifier: DIRECTION GENERALE DE LA SANTE )
First Submitted: May 10, 2011
First Posted: June 23, 2011
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Nestlé:
Prematurity
Nutrition
Growth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents