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Completed

NCT Number: NCT01375309

Bifidobacterium Supplementation for Very Low Birth Weight Infants

Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.

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Key information

Conditions

Preterm Infants

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokyo Women's Medical Unversity

Shinjuku, Tokyo, 162-8666, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with birth weight less than 1500g

Exclusion criteria

  • Sever bacteremia
  • Congenital anomaly
  • Not suitable for the trial defined by an attending neonatologist

Treatment and study plan

Bifidobacterium bifidum supplementation

Dietary Supplement

Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day

Other names: Bifidobacterium bifidum OLB6378

Placebo contains dextrin

Dietary Supplement

0.5 of dextrin

Primary outcomes

  1. Postnatal day when enteral feeding exceeded at 100ml/kg/day

    Time frame: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth

    Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.

Secondary outcomes

  1. standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)

    Time frame: For the duration of NICU stay, an expected average of 3 months

    BW gain/day, SD scores of BW and HC at discharge from NICU

  2. Necrotizing enterocolitis or sepsis

    Time frame: For the duration of NICU stay, an expected average of 3 months

    The incidences of necrtizing enterocolitis or sepsis during the stay in NICU

  3. Intestinal flora

    Time frame: For the duration of NICU stay, an expected average of 3 months

    Intestinal flora during the stay in NICU

Sponsors and collaborators

Lead sponsor

Tokyo Women's Medical University

Other

Registry information

Official study title

Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants

Acronym: Bifido(RCT)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 17, 2011
Registry last updated
Mar 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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