Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Neonatal Infection
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 3
- Rango de edad
- 0 días - 59 días
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 3250 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Zinc Supplementation
14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Zinc Supplements
Placebo
14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube
Dietary Supplement: Placebo Supplements
Zinc Supplements DIETARY_SUPPLEMENT
Dispersible zinc citrate tablets
Placebo Supplements DIETARY_SUPPLEMENT
Dispersible placebo tablets
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Death
Plazo: 90 Days
All-cause infant death
Treatment Failure
Plazo: 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
Medidas secundarias
Death during initial hospitalization
Plazo: Randomization to the date of initial hospitalization discharge, assessed up to 90 days
All-cause mortality during initial hospitalization
Duration of initial hospital stay
Plazo: Randomization to Day 90
Hours from randomization to initial hospitalization discharge
Duration of signs of clinical severe infection
Plazo: Randomization to Day 90
Hours from randomization to the absence of any sign of clinical severe infection
Diarrhea during initial hospital admission
Plazo: 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
Plazo: Randomization to Day 15
Vomiting observed by study staff within 30 minutes of regimen dosing
Re-hospitalization
Plazo: 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
Plazo: 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.
Presence of any sign of possible severe bacterial infection at Day 90
Plazo: 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
Plazo: Day 15 and Day 90
Maternal report of three or more loose or watery stools in the past 24 hours
Infant length-for-age z-score at Day 15
Plazo: Day 15
Infant length-for-age z-score by WHO Child Growth Standards
Infant length-for-age z-score at Day 90
Plazo: Day 90
Infant length-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 15
Plazo: Day 15
Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-age z-score at Day 90
Plazo: Day 90
Infant weight-for-age z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 15
Plazo: Day 15
Infant weight-for-length z-score by WHO Child Growth Standards
Infant weight-for-length z-score at Day 90
Plazo: Day 90
Infant weight-for-length z-score by WHO Child Growth Standard
Plasma zinc concentrations at Day 15
Plazo: Day 15
Infant plasma zinc concentration
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Muhimbili University of Health and Allied SciencesDar es Salaam, TanzaniaReclutando
Equipo y fechas
- Patrocinador principal
- Harvard School of Public Health (HSPH)
- Inicio del estudio
- 27 dic 2024 Real
- Finalización primaria
- 1 ene 2028 Estimado
- Finalización del estudio
- 1 ene 2028 Estimado
- Primera publicación
- 26 oct 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026