Probiotics Supplementation in Premature Infants

Probiotics Supplementation and Nutritional Benefit in Premature Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01379417

Enrollment

199

Registered

2011-06-23

Start date

2007-11-30

Completion date

2010-09-30

Last updated

2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity

Keywords

Prematurity, Nutrition, Growth

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.

Interventions

DIETARY_SUPPLEMENTProbiotic supplementation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 8 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Weight (g)	From 4 to 6 weeks after inclusion

Secondary

Measure	Time frame	Description
Growth	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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026