Insecticide-Treated Baby Wraps for the Prevention of Malaria
14 de agosto de 2026 atualizado por: University of North Carolina, Chapel Hill
Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
The proposed study is a double-blind, randomized control trial of permethrin-treated and etofenprox-treated lesus to prevent P. falciparum malaria in children 2-4 months of age conducted at three sites in rural Uganda.
Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment.
The total sample size will be 1,296 mother-infant pairs with 144 pairs in each group.
The investigators will follow participants longitudinally for three years.
Participants will be instructed and incentivized to present to one of the study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria.
Participants will also attend scheduled clinic visits every two months for routine surveillance of adverse effects and to test for asymptomatic infection.
Re-treatment and sham re-treatment of lesus will occur after 1 year of participation.
Participants will be asked to return the lesus after 2 years of participation.
Tipo de estudo
Intervencional
Inscrição (Estimado)
1296
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Ross Boyce, MD, MSc
- Número de telefone: 919-966-2537
- E-mail: ross_boyce@med.unc.edu
Locais de estudo
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-
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Mbarara, Uganda
- Mbarara University of Science and Technology
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Contato:
- Edgar Mulogo, PhD, MPH
- Número de telefone: 256-48540-20332
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Investigador principal:
- Edgar Mulogo, PhD, MPH
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Mother is at least 18 years old
- Mother has access to a working phone with a known number
- Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age
- Has the ability to travel to a designated study site for visits and evaluation
- Mother/Infant pair presents to their 10-week immunization visit at one of the designated study sites
Exclusion Criteria:
- Participation in another study of malaria prevention
- Known allergic reaction to permethrin or etofenprox
- Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
|
Patterned cotton-blend fabric will be obtained and treated with permethrin at Perimeter Insect Guard.
After treatment, the material will be cut into 2 x 1 meter swathes
|
|
Experimental: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
|
Patterned cotton-blend fabric will be obtained and treated with etofenprox at Perimeter Insect Guard.
After treatment, the material will be cut into 2 x 1 meter swathes
|
|
Comparador Falso: Receives non-treated lesu
Receives the non-treated lesu for 2 years
|
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of clinical malaria in children between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
|
Incidence of clinical malaria in children between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of clinical malaria in children between the permethrin and control arms per site
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
|
Incidence of clinical malaria in children between the etofenprox and control arms per site
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
|
Incidence of hospitalizations due to malaria between the permethrin and control arms
Prazo: From enrollment to Month 36
|
Incidence of admissions from clinic after a positive malaria RDT.
|
From enrollment to Month 36
|
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Incidence of hospitalizations due to malaria between the etofenprox and control arms
Prazo: From enrollment to Month 36
|
Incidence of admissions from clinic after a positive malaria RDT.
|
From enrollment to Month 36
|
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Number of deaths from any cause between the permethrin and control arms during wrap use
Prazo: From enrollment to Month 24
|
Number of deaths documented, regardless of cause.
|
From enrollment to Month 24
|
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Number of deaths from any cause between the etofenprox and control arms during wrap use
Prazo: From enrollment to Month 24
|
Number of deaths documented, regardless of cause.
|
From enrollment to Month 24
|
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Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued
Prazo: From Month 24 to Month 36
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Number of deaths documented, regardless of cause.
|
From Month 24 to Month 36
|
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Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued
Prazo: From Month 24 to Month 36
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Number of deaths documented, regardless of cause.
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From Month 24 to Month 36
|
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Number of deaths from malaria between the permethrin and control arms during wrap use
Prazo: From enrollment to Month 24
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Number of deaths documented during hospitalization.
|
From enrollment to Month 24
|
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Number of deaths from malaria between the etofenprox and control arms during wrap use
Prazo: From enrollment to Month 24
|
Number of deaths documented during hospitalization.
|
From enrollment to Month 24
|
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Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued
Prazo: From Month 24 to Month 36
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Number of deaths documented during hospitalization.
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From Month 24 to Month 36
|
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Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued
Prazo: From Month 24 to Month 36
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Number of deaths documented during hospitalization.
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From Month 24 to Month 36
|
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Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels
Prazo: At baseline, 12 Months, and 24 Months
|
Hemoglobin measured using a Hemocue device.
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At baseline, 12 Months, and 24 Months
|
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Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels
Prazo: At baseline, 12 Months, and 24 Months
|
Hemoglobin measured using a Hemocue device.
|
At baseline, 12 Months, and 24 Months
|
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Incidence of non-malarial febrile episodes in children between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
|
Incidence of non-malarial febrile episodes in children between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
|
From enrollment through Month 24
|
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Wrap attrition
Prazo: From enrollment through Month 24
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The number of wraps lost or damaged and requiring replacement.
|
From enrollment through Month 24
|
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Incidence of rebound clinical malaria in children between the permethrin and control arms
Prazo: From Month 24 through Month 36
|
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
|
From Month 24 through Month 36
|
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Incidence of rebound clinical malaria in children between the etofenprox and control arms
Prazo: From Month 24 through Month 36
|
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
|
From Month 24 through Month 36
|
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Number of adverse reactions to wraps between the permethrin and control arms
Prazo: From enrollment through Month 24
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Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
|
From enrollment through Month 24
|
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Number of adverse reactions to wraps between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
|
From enrollment through Month 24
|
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Number of participants with care-seeking events attributable to the permethrin wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with care-seeking events attributable to the permethrin wrap versus the control wrap.
|
From enrollment through Month 24
|
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Number of participants with care-seeking events attributable to the etofenprox wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control wrap.
|
From enrollment through Month 24
|
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Number of participants with hospitalizations attributable to the permethrin wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with hospitalizations attributable to the permethrin wrap versus the control wrap.
|
From enrollment through Month 24
|
|
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control wrap.
|
From enrollment through Month 24
|
|
Number of participants with death attributable to the permethrin wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with death attributable to the permethrin wrap versus the control wrap.
|
From enrollment through Month 24
|
|
Number of participants with death attributable to the etofenprox wrap versus the control
Prazo: From enrollment through Month 24
|
Number of participants with death attributable to the etofenprox wrap versus the control wrap.
|
From enrollment through Month 24
|
|
Change in child's height-for-weight between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for height-for-weight. A height-for-weight Z-score indicates how a child's height compares with a reference population of children of the same weight. A score of 0 represents the reference average; positive values indicate above-average height-for-weight, and negative values indicate below-average height-for-weight. Z = 0: Average height-for-weight in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's height-for-weight between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for height-for-weight. A height-for-weight Z-score indicates how a child's height compares with a reference population of children of the same weight. A score of 0 represents the reference average; positive values indicate above-average height-for-weight, and negative values indicate below-average height-for-weight. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's height-for-age between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for height-for-age. A height-for-age Z-score indicates how a child's height compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average height-for-age, and negative values indicate below-average height-for-age. Z = 0: Average height-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's height-for-age between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for height-for-age. Change in Z-score for height-for-age. A height-for-age Z-score indicates how a child's height compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average height-for-age, and negative values indicate below-average height-for-age. Z = 0: Average height-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's weight-for-age between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. A weight-for-age Z-score indicates how a child's weight compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average weight-for-age, and negative values indicate below-average weight-for-age. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's weight-for-age between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. Change in Z-score for weight-for-age. A weight-for-age Z-score indicates how a child's weight compares with a reference population of children of the same age. A score of 0 represents the reference average; positive values indicate above-average weight-for-age, and negative values indicate below-average weight-for-age. Z = 0: Average weight-for-age in the reference population Z = +1: One standard deviation above the reference average Z = -1: One standard deviation below the reference average Z = -2: Substantially below the reference average |
From enrollment through Month 24
|
|
Change in child's acute malnutrition between the permethrin and control arms
Prazo: From enrollment through Month 24
|
Change in Mid-upper arm circumference (MUAC).
|
From enrollment through Month 24
|
|
Change in child's acute malnutrition between the etofenprox and control arms
Prazo: From enrollment through Month 24
|
Change in Mid-upper arm circumference (MUAC).
|
From enrollment through Month 24
|
|
Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Change in median composite scores on the Mullen Scales of Early Learning.
The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning.
The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL.
It has a mean of 100 and a standard deviation of 15.
Higher scores indicate stronger performance.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's score on the Mullen Scales of Early Learning between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Change in mean composite scores on the Mullen Scales of Early Learning.
The Early Learning Composite from the Mullen Scales of Early Learning (MSEL) will be used to measure developmental functioning.
The Early Learning Composite (ELC) is a standardized composite score derived from the 5 subtests measured on the MSEL.
It has a mean of 100 and a standard deviation of 15.
Higher scores indicate stronger performance.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Physical Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4, which includes items measuring gross- and fine-motor skills, coordination, strength, stamina, and flexibility.
Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which includes items measuring age-appropriate independent functioning.
Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4, which includes items measuring skills related to interpersonal behavior and demonstration of social and emotional competence.
Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4, which includes items measuring perception, concept development, number relations, reasoning, memory, classification, time concepts, and related mental acuity tasks.
Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Communication Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4, which reflects the ability to understand spoken and written language as well as to use both verbal and nonverbal skills to communicate.
Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's percentile on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4. Expressed as a percentile from 0 to 100%, where a score of 50% indicates that the child performs equal to their same age peers, a score above 50% indicates they perform better than their same age peers, and a score below 50% indicates they perform worse than their same age peers.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Physical Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Communication Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's growth score on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4, which is expressed as a a raw score from 40 to 160 that is designed specifically to track progress and monitor developmental change over time, where higher scores indicate better performance
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Physical Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Physical subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Adaptive Behavior subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Social-Emotional Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Social-Emotional subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Cognitive Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Cognitive subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the permethrin and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
|
Change in child's age equivalent on the Developmental Profile 4: Communication Scale between the etofenprox and control arms
Prazo: Enrollment, Year 1, Year 2, Year 3
|
Performance on the Communication subscale of the Developmental Profile 4, which translates the child's performance to the age at which an average child achieves those same raw scores.
Expressed as a metric in the format X:Y where X equals the number of years old, and Y equals a number between 0 and 11.
Values higher than the child's age-equivalence reflects developmental functioning consistent with that of older children.
|
Enrollment, Year 1, Year 2, Year 3
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
1 de janeiro de 2030
Conclusão do estudo (Estimado)
1 de janeiro de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
14 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de agosto de 2026
Primeira postagem (Real)
19 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-1754
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Deidentified individual data that supports the results may be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Prazo de Compartilhamento de IPD
beginning 9 and continuing for 36 months following publication
Critérios de acesso de compartilhamento IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .