Effect of bifidbacterium bifidum supplementation on morbidity of very low birth weight infants

Not Applicable

• Conditions: very low birth weight infant

• Registration Number: JPRN-UMIN000002543
• Lead Sponsor: Maternal and Perinatal Center, Tokyo Women's Medical University

Brief Summary

A total of 291 VLBW infants were enrolled in the study, B group (n = 160) and P group (n = 131). Among them, 233 infants were established enteral feeding within 21 days after birth, and were received B.bifidum or Placebo until their body weight reached 2000g (119 and 114 infant respectively). There was a significant difference in the establishment of enteral feeding which was 11.0+-3.6 days in B group and 12.1+-3.8 days in P group, respectively (p<0.05). The growth of the infants during the stay in NICU was not different between the groups. However, the incidence of sepsis among all enrolled infants was significantly lower in B group (p<0.05). There was no difference in the incidence of other adverse outcomes. B.bifidum administration to VLBW infants accelerated their enteral feeding after birth without increasing of adverse effects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-01
• Study Completion: 2012-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

severe bacterila infection congenital anomaly not suitabel for the trial defined by the attending neonatologist

Study & Design

• Study Type: Interventional
• Study Design: Not specified