Probiotics Supplementation in Premature Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01379417
First received: May 10, 2011
Last updated: August 26, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Probiotics Supplementation and Nutritional Benefit in Premature Infants

Resource links provided by NLM:


Further study details as provided by Nestlé:

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

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

    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

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01379417     History of Changes
Other Study ID Numbers: 04.01.FR.INF, 2006-A00062-49
Study First Received: May 10, 2011
Last Updated: August 26, 2011
Health Authority: France : French Health Products Safety Agency (AFSSAPS)

Keywords provided by Nestlé:
Prematurity
Nutrition
Growth

ClinicalTrials.gov processed this record on July 22, 2014