Insecticide-Treated Baby Wraps for the Prevention of Malaria
14 août 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
1296
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Ross Boyce, MD, MSc
- Numéro de téléphone: 919-966-2537
- E-mail: ross_boyce@med.unc.edu
Lieux d'étude
-
-
-
Mbarara, Ouganda
- Mbarara University of Science and Technology
-
Contact:
- Edgar Mulogo, PhD, MPH
- Numéro de téléphone: 256-48540-20332
-
Chercheur principal:
- Edgar Mulogo, PhD, MPH
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Comparateur factice: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of clinical malaria in children between the etofenprox and control arms
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of clinical malaria in children between the permethrin and control arms per site
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 janvier 2027
Achèvement primaire (Estimé)
1 janvier 2030
Achèvement de l'étude (Estimé)
1 janvier 2031
Dates d'inscription aux études
Première soumission
14 août 2026
Première soumission répondant aux critères de contrôle qualité
14 août 2026
Première publication (Réel)
19 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-1754
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
beginning 9 and continuing for 36 months following publication
Critères d'accès au partage IPD
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .