None listed
Conditions
Brief summary
Introduction: One of the main cause of neonatal mortality in Afghanistan is preterm birth (35%). such baby faces a lot of problems included challenging weight gaining and feeding intolerance. The study hypothesis is dual strain probiotic will increase weight gaining and decreased feeding intolerance in very low birth weight preterm neonates. Objective: To compare the effectiveness of dual strain probiotic fortified milk versus non-fortified breast milk on weight gaining and feeding intolerance of preterm and low birth weight neonates Kabul hospitals. Method: Study Design is Randomized clinical Trail. The study population is comprised of preterm or low birth weight neonates at Malalai and Maiwand hospital in Kabul city during 2020. Sampling strategy:For this clinical trial, participants will select by block randomized sampling strategy. Totally the study will include 90 premature infants. 45 premature neonates would be feed by dual strain probiotic-fortified milk (Probiotic group), and the other 45 premature neonate will be feed by non-fortified milk (Control group).
Interventions
Group A or study group : In this group neonates will feed by mother breast milk together with Gutcare ( dual strain probiotic, a product of Searle, Pakistan) that each sachet containing 500mg Bifidobacterium and Clostridium butyricum, ( (1gr contain 12billion cfu so 500mg has 6 billion cfu). The half sachet (250mg) dissolved in 1-3ml milk and administrated orally twice daily. The probiotic-fortified milk will start from day 4 and continue for at least two weeks.
The routine management such as
Group A or study group : In this group neonates will feed by mother breast milk together with Gutcare ( dual strain probiotic, a product of Searle, Pakistan) that each sachet containing 500mg Bifidobacterium and Clostridium butyricum, ( (1gr contain 12billion cfu so 500mg has 6 billion cfu). The half sachet (250mg) dissolved in 1-3ml milk and administrated orally twice daily. The probiotic-fortified milk will start from day 4 and continue for at least two weeks. The routine management such as incubator care, fluid and electrolyte maintenance, Expressed Breast Milk (EBM) and premature formula via NGT for infants less than 1800gr or gestational age equal or less than 35weeks will undertake for two mentioned groups. EBM will initiates as trophic feeds of 10 to 20 mL/kg/day at 2 hourly interval in hemodynamically stable infants. Feeds will advance by 20 mL/kg/day up to 150ml/kg/day.
Sponsors
Professor Mansoor Aslamzai, MD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
Preterm neonates fulfill one of the following criteria’s will be enrolled in the study. 1- Gestational age of equal or less than 35weeks. 2- Weight less than 2000g.
Exclusion criteria
Neonates have visible or physically detected malformation, birth weight less than 1000gr, severe birth asphyxia, seriously ill baby and parent who declined consent.
Outcome results
None listed