Insecticide-Treated Baby Wraps for the Prevention of Malaria
2026년 8월 14일 업데이트: 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
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
1296
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ross Boyce, MD, MSc
- 전화번호: 919-966-2537
- 이메일: ross_boyce@med.unc.edu
연구 장소
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Mbarara, 우간다
- Mbarara University of Science and Technology
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연락하다:
- Edgar Mulogo, PhD, MPH
- 전화번호: 256-48540-20332
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수석 연구원:
- Edgar Mulogo, PhD, MPH
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
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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
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실험적: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
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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
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가짜 비교기: Receives non-treated lesu
Receives the non-treated lesu for 2 years
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Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of clinical malaria in children between the etofenprox and control arms
기간: From enrollment through Month 24
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Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
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From enrollment through Month 24
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Incidence of clinical malaria in children between the permethrin and control arms
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of clinical malaria in children between the permethrin and control arms per site
기간: 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
기간: 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
|
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Incidence of hospitalizations due to malaria between the permethrin and control arms
기간: From enrollment to Month 36
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Incidence of admissions from clinic after a positive malaria RDT.
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From enrollment to Month 36
|
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Incidence of hospitalizations due to malaria between the etofenprox and control arms
기간: From enrollment to Month 36
|
Incidence of admissions from clinic after a positive malaria RDT.
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From enrollment to Month 36
|
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Number of deaths from any cause between the permethrin and control arms during wrap use
기간: From enrollment to Month 24
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Number of deaths documented, regardless of cause.
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From enrollment to Month 24
|
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Number of deaths from any cause between the etofenprox and control arms during wrap use
기간: From enrollment to Month 24
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Number of deaths documented, regardless of cause.
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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
기간: 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 any cause between the etofenprox and control arms after wrap use has been discontinued
기간: 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
기간: From enrollment to Month 24
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Number of deaths documented during hospitalization.
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From enrollment to Month 24
|
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Number of deaths from malaria between the etofenprox and control arms during wrap use
기간: From enrollment to Month 24
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Number of deaths documented during hospitalization.
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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
기간: 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
기간: 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
기간: At baseline, 12 Months, and 24 Months
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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
기간: 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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Incidence of non-malarial febrile episodes in children between the permethrin and control arms
기간: 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
기간: From enrollment through Month 24
|
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
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From enrollment through Month 24
|
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Wrap attrition
기간: From enrollment through Month 24
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The number of wraps lost or damaged and requiring replacement.
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From enrollment through Month 24
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Incidence of rebound clinical malaria in children between the permethrin and control arms
기간: From Month 24 through Month 36
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Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
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From Month 24 through Month 36
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Incidence of rebound clinical malaria in children between the etofenprox and control arms
기간: From Month 24 through Month 36
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Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
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From Month 24 through Month 36
|
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Number of adverse reactions to wraps between the permethrin and control arms
기간: 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.
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From enrollment through Month 24
|
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Number of adverse reactions to wraps between the etofenprox and control arms
기간: From enrollment through Month 24
|
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
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From enrollment through Month 24
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Number of participants with care-seeking events attributable to the permethrin wrap versus the control
기간: From enrollment through Month 24
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Number of participants with care-seeking events attributable to the permethrin wrap versus the control wrap.
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From enrollment through Month 24
|
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Number of participants with care-seeking events attributable to the etofenprox wrap versus the control
기간: From enrollment through Month 24
|
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control wrap.
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From enrollment through Month 24
|
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Number of participants with hospitalizations attributable to the permethrin wrap versus the control
기간: 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
기간: From enrollment through Month 24
|
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control wrap.
|
From enrollment through Month 24
|
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Number of participants with death attributable to the permethrin wrap versus the control
기간: 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
기간: From enrollment through Month 24
|
Number of participants with death attributable to the etofenprox wrap versus the control wrap.
|
From enrollment through Month 24
|
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Change in child's height-for-weight between the permethrin and control arms
기간: 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
|
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Change in child's height-for-weight between the etofenprox and control arms
기간: 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
|
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Change in child's height-for-age between the permethrin and control arms
기간: 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
기간: 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
기간: 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
기간: 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
|
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Change in child's acute malnutrition between the permethrin and control arms
기간: From enrollment through Month 24
|
Change in Mid-upper arm circumference (MUAC).
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From enrollment through Month 24
|
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Change in child's acute malnutrition between the etofenprox and control arms
기간: From enrollment through Month 24
|
Change in Mid-upper arm circumference (MUAC).
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From enrollment through Month 24
|
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Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms
기간: 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
|
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Change in child's score on the Mullen Scales of Early Learning between the etofenprox and control arms
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 1일
기본 완료 (추정된)
2030년 1월 1일
연구 완료 (추정된)
2031년 1월 1일
연구 등록 날짜
최초 제출
2026년 8월 14일
QC 기준을 충족하는 최초 제출
2026년 8월 14일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 14일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 26-1754
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
beginning 9 and continuing for 36 months following publication
IPD 공유 액세스 기준
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .