Status:
TERMINATED
Probiotics for Prevention Neonatal Infection
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Neonatal Sepsis
Sepsis
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world's largest populations, conti...
Detailed Description
Our current study is an attempt to put the well known concept of probiotics through rigorous scientific testing before it could be recommended as a prophylactic therapy against neonatal infections. Th...
Eligibility Criteria
Inclusion
- All newborn infants in the community \>24 hours and \<72 hours of age
- 2000 g at birth
- Breastfeeding begun by 24 hr of life
- Able to tolerate oral feeds
- Informed consent by parent or guardian
Exclusion
- Evidence or suspicion of clinical sepsis before the baby is randomized
- Not on breast feeding by 24 hr
- Inability to establish oral feeds (in case of maternal death or ailment)
- Presence of major congenital anomalies
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
4556 Patients enrolled
Trial Details
Trial ID
NCT01214473
Start Date
June 1 2007
End Date
November 1 2013
Last Update
August 23 2023
Active Locations (2)
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1
Center for Advanced Research on Alternative Medicine
Bhubaneswar, Odisha, India, 751009
2
Ispat General Hospital
Rourkela, Odisha, India, 769002