Necrotizing Enterocolitis, Death
Conditions
Keywords
probiotics, preterm very low birth weight infants, necrotizing enterocolitis, gut microflora, TLR, NF-KB, inflammatory factors
Brief summary
The purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.
Detailed description
Necrotizing enterocolitis (NEC) remains the most catastrophic gastrointestinal emergencies in preterm very low birth weight (VLBW) infants.Although study showed it is a multifactorial disease, its pathogenesis is still not yet unclear currently. Prematurity and formula feeding is considered as the main risk factors.Gut microbiota disturbance and immature immune system is associated with NEC. A lot of studies had showed that oral probiotics can alter gut microbiota flora colonization and reduce the incidence of NEC,but the exact mechanism remains unclear.The aim of this study is to elucidate the clinical efficacy and possible molecular mechanism of oral mixture probiotics in preventing NEC among preterm VLBW infants. Patient Registry procedures: First,randomized numbers was generated by the computer and sent to the principal investigator(PI) at each center when an infant was eligible for enrollment.Second, patient will be assigned randomly to experimental group or control group by PI.Finally,the PI at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection. Sample size determination: The incidence of death and NEC was around 20% recently.To reduce the incidence of NEC and death to 10% at discharge would require a 50% improvement.At 80% power at P = 0.05 (two-sided),the loss rate of 0.2, this would require 135 subjects per arm. Statistical analysis:The two groups were compared by a Χ2-test for categorical variables,Mann-Whitney U Test were used when reporting medians.A P value of \<0.05 was considered statistically significant.
Interventions
DIETARY_SUPPLEMENTprobiotics
Administration of mixture probiotics 500mg by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.
DIETARY_SUPPLEMENTglucose solution
Administration of 1 mL of a 5% glucose solution by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.
Sponsors
China Medical University Hospital
Shenzhen People's Hospital
Shenzhen Sixth People's Hospital
Longhua Hospital Of Baoan District, Shenzhen
Shenzhen Bao'an Maternal and Child Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No
Inclusion criteria
* Preterm infants ≦ 34 weeks gestational age and birth weight below 1500 gm and who survive to NICU are eligible for the trial.
Exclusion criteria
* severe asphyxia (stage III), * fetal chromosomal anomalies, * cyanotic congenital heart disease, * congenital intestinal atresia, gastroschisis, omphalocele, active upper gastric intestinal bleeding, * lacking/refused of parental consent, * those who are fasted for \>3 weeks during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of combined death and necrotizing enterocolitis | at 36 weeks correct gestational age |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of sepsis,intraventricular hemorrhage(IVH)(grade 3-4),feeding intolerance(FI),bronchopulmonary dysplasia(BPD),parenteral nutrition associated liver disease(PNALD)and retinopathyof prematurity(ROP). | participants will be followed for the duration of hospital stay, an expected average of 8 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| the influence of oral probiotics on gut microbiota and immunomodulatory | at birth, 2 and 4 weeks of life, 36 week correct gestational age. | test fecal microbiota via high throughput sequencing and blood toll like receptor(TLR)2,TLR4,neclear factor kappa B(NF-KB)were detected using flow cytomtry.Inflammatory factors of blood were tested via Cytometric Bead Array(CBA).All above samples were obtained only from Shenzhen Bao'an Maternal and Child Health Hospital.The fecal DNA were first extracted at centre laboratory in aboved hospital and sent them to Beijing Genomics Institute(BGI) for further sequenceing ,if necessary, quantitative polymerase chain reaction(qPCR)of gut dominant bacterias related to late onset sepsis(LOS) will be tested for assessing the effect of oral probiotics on gut microbiota and underlying the mechanism. Flow cytometry analysis of TLR2,TLR4 and NF-KB were made by the senior laboratorian of our department and resposible for the accuracy of experimental result. CBA of inflammatory factors will be made by senting the blood samples to Beijing JIAMAY BIOLAB. |
Countries
China
Contacts
Primary ContactYuefeng Li, M.D.
Outcome results
None listed