Effect of Oral Probiotic Supplementation on The Rate of Hospital Acquired Infection and Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants

NCT01340469 | Completed Phase 3

• 1 other identifier: 076/2003
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.

Conditions

Nosocomial Infection; Necrotizing Enterocolitis

Keywords

nosocomial infections; necrotizing enterocolitis; preterm infants; ver low birth weight; probiotics

Outcome Measures

Primary Outcomes (1)

• incidence of nosocomial infections

  Nosocomial infections , defined as any major infection occurring during the hospitalization, not earlier than 5 days of life.(sepsis, pneumonia, NEC, meningitis, omphalitis, osteomyelitis, soft tissue infection etc.). Sepsis was defined as a clinical syndrome of systemic illness accompanied by positive blood culture.

  28 days or until discharge

Secondary Outcomes (3)

• incidence of necrotizing enterocolitis (NEC)

  28 days or until discharge

• feeding tolerance

  28 days

• time to full enteral feeding

  28 days

Study Arms (2)

study

ACTIVE COMPARATOR

Probiotics supplementation .

Biological: probiotics

control

PLACEBO COMPARATOR

The control group received daily placebo liquid .

Biological: probiotics

Interventions

probiotics BIOLOGICAL

Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.

Also known as: Infloran (Swiss Berna)

control; study

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Very Low Birth Weight (VLBW) preterm infants (Gestational age \< 35 weeks , BW \< 1500 g ) admitted to the NICU who survived the first 3 days of life

You may not qualify if:

• Infants with chromosome abnormality or severe congenital defects, especially gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) and infants with unstable hemodynamic status

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Faculty of Medicine Chilalongkorn University

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Cross Infection; Enterocolitis, Necrotizing

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Santi Punnahitananda, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 22, 2011
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 22, 2011

Record last verified: 2011-03

Locations

TH (1)