Necrotizing Enterocolitis, Nosocomial Infection
Conditions
Keywords
nosocomial infections, necrotizing enterocolitis, preterm infants, ver low birth weight, probiotics
Brief summary
The purpose of this study is to determine whether oral probiotic supplementation could reduce the incidence of nosocomial infections in preterm infants.
Detailed description
There are growing numbers of evidence indicating the beneficial effects of normal enteric flora (probiotics) with regard to the host defense against infection. In vitro and in vivo studies have shown that probiotics such as lactobacilli and bifidobacteria have inhibitory effects on other pathogenic bacteria.This evidence, along with the results of recent clinical studies, has demonstrated the beneficial effects of probiotics in the prevention of NEC in VLBW infants.However, most of the studies reported nosocomial infection as a secondary outcome and the findings were controversial regarding probiotics efficacy in preventing nosocomial infections. There is only one study that was aimed to investigate effects of probiotic on the incidence of nosocomial infection. Given the potential benefit of probiotics against infection and the lack of clinical studies in this regard, we conducted a randomized clinical trial to determine whether probiotic supplementation (in the form of Lactobacillus acidophilus and Bifidobacterium infantis) could reduce nosocomial infection rate among preterm VLBW infants in a intensive care nursery setting.
Interventions
BIOLOGICALprobiotics
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.
Sponsors
King Chulalongkorn Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Days to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of nosocomial infections | 28 days or until discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of necrotizing enterocolitis (NEC) | 28 days or until discharge | necrotizing enterocolitis (NEC), which was identified and categorized by modified Bell's classification |
| feeding tolerance | 28 days | the volume of feeding on day 7,14,21, and 28 of study |
| time to full enteral feeding | 28 days | time required to reach full feeding at 150 ml/kg/day |
Countries
Thailand
Outcome results
None listed