Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
- Conditions
- Neonatal Infection
- Interventions
- Dietary Supplement: Zinc SupplementsDietary Supplement: Placebo Supplements
- Registration Number
- NCT06102044
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3250
- Young infants aged 0-59 days
- Diagnosis of clinical severe infection (CSI)
- Ability to feed enterally
- Intend to stay in the study area for 90 days
- Provided informed consent
- Prior use of zinc supplements during the current illness
- Receipt of antibiotics for >24 hours before enrollment
- Diarrhea at enrollment
- Signs suggestive of serious illness/condition that is not clinical severe infection
- Previously enrolled in the trial
- Enrolled in other research study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc Supplementation Zinc Supplements 14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube Placebo Placebo Supplements 14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
- Primary Outcome Measures
Name Time Method Death 90 Days All-cause infant death
Treatment Failure From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization
- Secondary Outcome Measures
Name Time Method Death during initial hospitalization Randomization to the date of initial hospitalization discharge, assessed up to 90 days All-cause mortality during initial hospitalization
Duration of initial hospital stay Randomization to Day 90 Hours from randomization to initial hospitalization discharge
Duration of signs of clinical severe infection Randomization to Day 90 Hours from randomization to the absence of any sign of clinical severe infection
Infant length-for-age z-score at Day 15 Day 15 Infant length-for-age z-score by WHO Child Growth Standards
Infant length-for-age z-score at Day 90 Day 90 Infant length-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 15 Day 15 Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 90 Day 90 Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 15 Day 15 Infant weight-for-length z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 90 Day 90 Infant weight-for-length z-score by WHO Child Growth Standard
Plasma zinc concentrations at Day 15 Day 15 Infant plasma zinc concentration
Re-hospitalization Date of initial hospitalization discharge to Day 90 Infant admitted and stayed overnight in health facility after being discharged from initial hospitalization
Presence of any sign of possible severe bacterial infection at Day 15 Day 15 Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature \<35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions.
Diarrhea during initial hospital admission Randomization to the date of initial hospitalization discharge, assessed up to 90 days Clinical diagnosis based on three or more loose or watery stools in the past 24 hours
Rate of vomiting related to regimen dosing Randomization to Day 15 Vomiting observed by study staff within 30 minutes of regimen dosing
Presence of any sign of possible severe bacterial infection at Day 90 Day 90 Presence of a clinical sign of possible severe bacterial infection, including: high body temperature ≥38°C, low body temperature \<35.5°C , severe chest indrawing, movement only on stimulation or no movement at all, stopped feeding well or unable to feed at all, or convulsions.
Proportion of Children with Diarrhea at Day 15 or Day 90 Day 15 and Day 90 Maternal report of three or more loose or watery stools in the past 24 hours
Trial Locations
- Locations (1)
Muhimbili University of Health and Allied Sciences
🇹🇿Dar Es Salaam, Tanzania