Necrotizing Enterocolitis, Sepsis
Conditions
Keywords
Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938
Brief summary
The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration
Interventions
The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
DRUGPlacebo
expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
Sponsors
Children's Hospital and Institute of Child Health, Multan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 34 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Preterm neonate\< 34 weeks and \>28 weeks of gestation of both genders Hemodynamically stable
Exclusion criteria
* Preterm neonates \>34 weeks gestational age \< 28 weeks of gestation Cardiorespiratory illness Parental refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| narcotizing enterocolitis | up to 35 weeks of gestation | number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sepsis | At time of addmission and 15 days after intervention | number of participants who developed sepsis proven by blood cultures before of after intervention |
Contacts
Primary ContactSTabasum
Outcome results
None listed