Prevention of Infection in Indian Neonates - Phase II Probiotics Study (NCT00518596) | Clinical Trial Compass
CompletedPhase 2
Prevention of Infection in Indian Neonates - Phase II Probiotics Study
India284 participantsStarted 2005-07
Plain-language summary
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Who can participate
Age range
72 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants ≥ 35 weeks and ≥1800g born in the hospital
* Infants \> 12 hours and \< 72 hours of age at enrollment
* Infants likely to be hospitalized for 5-7 days without antibiotic treatment
* Informed consent by one parent or guardian
* Infants begun breastfeeding
Exclusion Criteria:
* Antibiotic therapy prior to enrollment
* Evidence or suspicion of clinical sepsis before randomization
* Inability (as determined by the physician) to tolerate oral feeding of study supplement
* Presence of major congenital anomalies
* Infant's home is \>30km away from hospital A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration.
Timeframe: 28 days
2
Clinical safety (including sepsis and death) and tolerance of a daily administration of oral L. plantarum probiotic supplement when used in healthy full-term neonates.
Timeframe: 28 days
3
Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement.
Trial details
NCT IDNCT00518596
SponsorNICHD Global Network for Women's and Children's Health