Insecticide-Treated Baby Wraps for the Prevention of Malaria
14. august 2026 opdateret af: 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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1296
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ross Boyce, MD, MSc
- Telefonnummer: 919-966-2537
- E-mail: ross_boyce@med.unc.edu
Studiesteder
-
-
-
Mbarara, Uganda
- Mbarara University of Science and Technology
-
Kontakt:
- Edgar Mulogo, PhD, MPH
- Telefonnummer: 256-48540-20332
-
Ledende efterforsker:
- Edgar Mulogo, PhD, MPH
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
|
Sham-komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of clinical malaria in children between the etofenprox and control arms
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of clinical malaria in children between the permethrin and control arms per site
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Change in child's age equivalent on the Developmental Profile 4: Adaptive Behavior Scale between the etofenprox and control arms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2027
Primær færdiggørelse (Anslået)
1. januar 2030
Studieafslutning (Anslået)
1. januar 2031
Datoer for studieregistrering
Først indsendt
14. august 2026
Først indsendt, der opfyldte QC-kriterier
14. august 2026
Først opslået (Faktiske)
19. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-1754
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
beginning 9 and continuing for 36 months following publication
IPD-delingsadgangskriterier
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .