Insecticide-Treated Baby Wraps for the Prevention of Malaria
14 августа 2026 г. обновлено: 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
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
1296
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Ross Boyce, MD, MSc
- Номер телефона: 919-966-2537
- Электронная почта: ross_boyce@med.unc.edu
Места учебы
-
-
-
Mbarara, Уганда
- Mbarara University of Science and Technology
-
Контакт:
- Edgar Mulogo, PhD, MPH
- Номер телефона: 256-48540-20332
-
Главный следователь:
- Edgar Mulogo, PhD, MPH
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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
|
|
Экспериментальный: 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
|
|
Фальшивый компаратор: 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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of clinical malaria in children between the etofenprox and control arms
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of clinical malaria in children between the permethrin and control arms per site
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From enrollment to Month 36
|
Incidence of admissions from clinic after a positive malaria RDT.
|
From enrollment to Month 36
|
|
Incidence of hospitalizations due to malaria between the etofenprox and control arms
Временное ограничение: From enrollment to Month 36
|
Incidence of admissions from clinic after a positive malaria RDT.
|
From enrollment to Month 36
|
|
Number of deaths from any cause between the permethrin and control arms during wrap use
Временное ограничение: From enrollment to Month 24
|
Number of deaths documented, regardless of cause.
|
From enrollment to Month 24
|
|
Number of deaths from any cause between the etofenprox and control arms during wrap use
Временное ограничение: From enrollment to Month 24
|
Number of deaths documented, regardless of cause.
|
From enrollment to Month 24
|
|
Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued
Временное ограничение: From Month 24 to Month 36
|
Number of deaths documented, regardless of cause.
|
From Month 24 to Month 36
|
|
Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued
Временное ограничение: From Month 24 to Month 36
|
Number of deaths documented, regardless of cause.
|
From Month 24 to Month 36
|
|
Number of deaths from malaria between the permethrin and control arms during wrap use
Временное ограничение: From enrollment to Month 24
|
Number of deaths documented during hospitalization.
|
From enrollment to Month 24
|
|
Number of deaths from malaria between the etofenprox and control arms during wrap use
Временное ограничение: From enrollment to Month 24
|
Number of deaths documented during hospitalization.
|
From enrollment to Month 24
|
|
Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued
Временное ограничение: From Month 24 to Month 36
|
Number of deaths documented during hospitalization.
|
From Month 24 to Month 36
|
|
Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued
Временное ограничение: From Month 24 to Month 36
|
Number of deaths documented during hospitalization.
|
From Month 24 to Month 36
|
|
Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels
Временное ограничение: At baseline, 12 Months, and 24 Months
|
Hemoglobin measured using a Hemocue device.
|
At baseline, 12 Months, and 24 Months
|
|
Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels
Временное ограничение: At baseline, 12 Months, and 24 Months
|
Hemoglobin measured using a Hemocue device.
|
At baseline, 12 Months, and 24 Months
|
|
Incidence of non-malarial febrile episodes in children between the permethrin and control arms
Временное ограничение: 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
Временное ограничение: 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
|
|
Wrap attrition
Временное ограничение: From enrollment through Month 24
|
The number of wraps lost or damaged and requiring replacement.
|
From enrollment through Month 24
|
|
Incidence of rebound clinical malaria in children between the permethrin and control arms
Временное ограничение: 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
|
|
Incidence of rebound clinical malaria in children between the etofenprox and control arms
Временное ограничение: 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
|
|
Number of adverse reactions to wraps between the permethrin and control arms
Временное ограничение: 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
|
|
Number of adverse reactions to wraps between the etofenprox and control arms
Временное ограничение: 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
|
|
Number of participants with care-seeking events attributable to the permethrin wrap versus the control
Временное ограничение: 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
|
|
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control
Временное ограничение: 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
|
|
Number of participants with hospitalizations attributable to the permethrin wrap versus the control
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 января 2027 г.
Первичное завершение (Оцененный)
1 января 2030 г.
Завершение исследования (Оцененный)
1 января 2031 г.
Даты регистрации исследования
Первый отправленный
14 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
14 августа 2026 г.
Первый опубликованный (Действительный)
19 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 26-1754
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
beginning 9 and continuing for 36 months following publication
Критерии совместного доступа к IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .