Sepsis
Conditions
Keywords
Neonatal, Sepsis, Global Network, Probiotics, India, International, Maternal and child health
Brief 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.
Detailed description
Phase II is a hospital based intervention (n = 297 infants) measuring the colonizing ability, safety, and tolerance of a probiotic supplement, Lactobacillus plantarum in the neonatal gut. Newborn infants ≥ 35 weeks of gestation will be randomized to receive either L. plantarum preparations (containing 109 organisms) or placebo preparations orally once a day for the first 7 days of life. The final stage of the project will be a community-based randomized double-blind placebo-controlled trial of L. plantarum enrolling over 8,000 newborns to examine the efficacy of probiotic supplementation in reducing neonatal infection in Indian neonates.
Interventions
DIETARY_SUPPLEMENTProbiotic supplementation (Lactobacillus plantarum)
GastroPlan capsules from a single lot will be used. The intervention consists of L. plantarum reconstituted in sterile 2.0 cc of 5% dextrose-saline, administered orally using an opaque-amber syringe.
Sponsors
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Fogarty International Center of the National Institute of Health
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
All India Institute of Medical Sciences
TN Medical College, Mumbai
Department of Health and Family Welfare, Orissa
SCB Medical College, Cuttack
Capital Hospital, Bhubaneswar
Ispat General Hospital, Rourkela
Kalinga Hospital, Bhubaneswar
University of Maryland
NICHD Global Network for Women's and Children's Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonizing ability of L. plantarum in Indian neonates after 5-7 days of administration. | 28 days |
| 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. | 28 days |
| Changes in stool microfloral patterns with 5-7 day administration of L. plantarum supplement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of the future community study (consent and retention rates, completeness of stool sampling, ability to complete the study in the home for infants discharged early). | — |
Countries
India
Outcome results
None listed