NCT01379417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

May 10, 2011

Last Update Submit

August 26, 2011

Conditions

Prematurity

Keywords

PrematurityNutritionGrowth

Outcome Measures

Primary Outcomes (1)

  • Weight (g)

    From 4 to 6 weeks after inclusion

Secondary Outcomes (1)

  • Growth

    between inclusion date and 4 to 6 weeks after inclusion (= end of supplementation period)

Study Arms (4)

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Probiotic supplementation

Probiotic B lactis/B longum

ACTIVE COMPARATOR

Bifidobacterium lactis + Bifidobacterium longum

Dietary Supplement: Probiotic supplementation

Probiotic B longum

ACTIVE COMPARATOR

Bifidobacterium longum

Dietary Supplement: Probiotic supplementation

Probiotic B lactis

ACTIVE COMPARATOR

Bifidobacterium lactis

Dietary Supplement: Probiotic supplementation

Interventions

Probiotic supplementationDIETARY_SUPPLEMENT

1 capsule per day, from inclusion to 4 or 6 weeks after inclusion

MaltodextrinProbiotic B lactisProbiotic B lactis/B longumProbiotic B longum

Eligibility Criteria

Age1 Day - 8 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • Enteral/Oral feeding termination during more than 72 hours due to severe digestive disorders (\> or equal to 2a on Bell stage )
  • Serious digestive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service de Nénatologie, Hôpital Femme Mère Enfant

Bron, 69678, France

Location

Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Service de Réanimation Néonatale, Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Publications (1)

  • Hays S, Jacquot A, Gauthier H, Kempf C, Beissel A, Pidoux O, Jumas-Bilak E, Decullier E, Lachambre E, Beck L, Cambonie G, Putet G, Claris O, Picaud JC. Probiotics and growth in preterm infants: A randomized controlled trial, PREMAPRO study. Clin Nutr. 2016 Aug;35(4):802-11. doi: 10.1016/j.clnu.2015.06.006. Epub 2015 Jul 16.

    PMID: 26220763DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jean-Charles Picaud, Pr

    Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

June 23, 2011

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

FR(3)