Clinical Trials Logo
  1. Home
  2. Neonatal Infection
  3. NCT06102044

Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Neonatal Infection Clinical Trial

Official title:
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

Clinical Trial Summary

Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection. The Investigators will conduct a randomized, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06102044
Study type Interventional
Source Harvard School of Public Health (HSPH)
Contact Christopher R Sudfeld, ScD
Phone (617) 432-5051
Email csudfeld@hsph.harvard.edu
Status Not yet recruiting
Phase Phase 3
Start date June 30, 2024
Completion date June 1, 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT04200807 - Non-invasive Measurement of Neonatal Central and Peripheral Hemodynamics
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1
Completed NCT01729000 - Study to Determine if Gloving in Addition to Hand Hygiene Will Prevent Invasive Infections and Necrotizing Enterocolitis N/A
Completed NCT06413056 - Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection Phase 4
Completed NCT03247920 - Reduction of Intravenous Antibiotics In Neonates Phase 4
Completed NCT02486783 - Infection, Sepsis and Meningitis in Surinamese Neonates N/A
Recruiting NCT06194396 - Effect of Chlorhexidine Versus Alcohol on Infections in Neonates N/A
Active, not recruiting NCT05343403 - Parental Participation on the Neonatal Ward - the neoPARTNER Study
Recruiting NCT04416373 - COVID-19 and Pregnancy Outcomes
Completed NCT01540162 - Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement N/A
Withdrawn NCT03673566 - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - CHMCO N/A
Completed NCT04883801 - Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
Terminated NCT05379452 - Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
Active, not recruiting NCT04718220 - Safety, Testing/Transmission, and Outcomes in Pregnancies With COVID-19 N/A
Active, not recruiting NCT04433364 - COPE - COVID-19 in Pregnancy and Early Childhood
Completed NCT03383211 - Immune Response to BCG Vaccination in Neonates Born to HIV and LTBI Infected and Non-infected Mothers
Completed NCT04893343 - Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Withdrawn NCT03673579 - Clinical Evaluation of the "NICU Clinical Decision Support Dashboard" - MHSB N/A
Completed NCT04206878 - Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
Recruiting NCT05743816 - Neonatal Antimicrobial Resistance and Outcome