Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies

Hayatabad Medical Complex

Status: Not yet enrolling

Conditions: NEC - Necrotizing Enterocolitis; NEC

Treatments: Drug: Probiotic; Drug: 10% dextrose

Study type: Interventional

Funder types: Other

Identifiers

NCT07233382

Agha Khan (Other Grant/Funding Number)

ERB # 2731

Details and patient eligibility

About

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.

Full 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

Enrollment: 196 estimated patients

Sex: All

Ages: Under 1 day old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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196 participants in 2 patient groups, including a placebo group

Probiotic group - Intervention

Active Comparator group

Description:

This group will receive intervention

Treatment:

Drug: Probiotic

Placebo

Placebo Comparator group

Description:

This group will receive 10% DW

Treatment:

Drug: 10% dextrose