NEC, NEC - Necrotizing Enterocolitis
Conditions
Brief summary
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
Detailed description
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
Interventions
DRUGProbiotic
All preterm babies \<34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group. Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp. * Dose is 1 million international units (0.2ml or 5 drops) OD * Started as soon as feed is in initiated
DRUG10% dextrose
This will receive 10% DW as placebo
Sponsors
Hayatabad Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Days
Healthy volunteers
Yes
Inclusion criteria
* Male and female preterm infants with a gestational age less than 35 weeks. * All indoor patients and outdoor patients who present within 24hrs of birth
Exclusion criteria
* • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis. * Infants with severe sepsis or gastrointestinal bleeding on presentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who develop NEC on probiotic vs placebo | 30 days |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORRomisa Romisa, MBBS, FCPS
Hyatabad Medical Complex
Outcome results
None listed