Necrotizing Enterocolitis Clinical Trial
Official title:
Nosocomial Infections and Necrotizing Enterocolitis in Preterm Neonates Treated With Lactobacillus Acidophilus and Bifidobacterium Infantis in An Intensive Care Unit : A Randomized Controlled Study
Verified date | March 2011 |
Source | King Chulalongkorn Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 28 Days |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Infants with chromosome abnormality or severe congenital defects, especially gastrointestinal anomalies (e.g. omphalocele, gastroschisis, intestinal obstruction) and infants with unstable hemodynamic status |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Faculty of Medicine Chilalongkorn University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
King Chulalongkorn Memorial Hospital |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | incidence of necrotizing enterocolitis (NEC) | necrotizing enterocolitis (NEC), which was identified and categorized by modified Bell's classification | 28 days or until discharge | No |
Secondary | feeding tolerance | the volume of feeding on day 7,14,21, and 28 of study | 28 days | No |
Secondary | time to full enteral feeding | time required to reach full feeding at 150 ml/kg/day | 28 days | No |
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