Ignite Creation Date:
2024-05-06 @ 8:02 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02650869
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2015-12-31
Brief Title:
Role of Probiotics for Prevention of NEC in Preterm VLBW Infants
Sponsor:
Sylhet MAGOsmani Medical College
Organization:
Sylhet MAGOsmani Medical College
Study Overview
Official Title:
Role of Probiotics for Prevention of Necrotizing Enterocolitis in Preterm Very Low Birth Weight Infants A Double Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Probiotics
Brief Summary:
This prospective randomized double-blind control trial is carrying out in the neonatal unit of Sylhet MAG Osmani Medical College Hospital Sylhet between July 2012 to December 2015 with the diagnosis of preterm 33 weeks gestation VLBW birth weight 1500g and fulfilling the inclusion criteria able to tolerate oral feed and survive beyond 48h of life were included in this study Babies with suspicion of clinical sepsis presence of perinatal asphyxia major congenital anomaly and babies who expired due to other neonatal illness were excluded Gestation was assessed from history of last menstrual period and after birth by new Ballard scores A study protocol was approved by the Institutional Ethics Committee of Sylhet MAG Osmani Medical College Sylhet
Detailed Description:
Background Necrotizing enterocolitis NEC is the most common acquired disease of the gastrointestinal tract in preterm very low birth weight infants and associated with increased morbidity and mortality Prophylactic enteral probiotic supplementation may play a role in reducing NEC and potentially provide benefits to preterm very low birth weight neonates The objective was to evaluate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis NEC in preterm very low birth weight VLBW infants
This prospective randomized double blind controlled trial is undergoing in 102 preterm 28-33 weeks gestation VLBW birth weight 1000-1499g neonates fulfilling the inclusion criteria The study group was fed with probiotics once daily with breast milk from first feeding and the control group only breast milk without the addition of probiotics The primary outcome was the development of NEC stage II and III NEC is categorized by modified Bells classification
Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight It is also associated with faster achievement of full enteral feeding and shorter duration of hospital stay
This prospective randomized double blind controlled trial is undergoing in 102 preterm 28-33 weeks gestation VLBW birth weight 1000-1499g neonates fulfilling the inclusion criteria The study group was fed with probiotics once daily with breast milk from first feeding and the control group only breast milk without the addition of probiotics The primary outcome was the development of NEC stage II and III NEC is categorized by modified Bells classification
Probiotic supplementation reduces the frequency of necrotising enterocolitis in preterm neonates with very low birth weight It is also associated with faster achievement of full enteral feeding and shorter duration of hospital stay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None