Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Insecticide-Treated Baby Wraps for the Prevention of Malaria

14 sierpnia 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1296

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Uganda
      • Mbarara, Uganda
        • Mbarara University of Science and Technology
        • Kontakt:
          • Edgar Mulogo, PhD, MPH
          • Numer telefonu: 256-48540-20332
        • Główny śledczy:
          • Edgar Mulogo, PhD, MPH

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
Inny: Permethrin-treated lesu
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
Eksperymentalny: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
Inny: Etofenprox-treated lesu
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
Pozorny komparator: Receives non-treated lesu
Receives the non-treated lesu for 2 years
Inny: Untreated lesu
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Incidence of clinical malaria in children between the etofenprox and control arms
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of clinical malaria in children between the permethrin and control arms per site
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of North Carolina, Chapel Hill

Współpracownicy

Mbarara University of Science and Technology
North Carolina State University

Śledczy

  • Główny śledczy: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 stycznia 2027

Zakończenie podstawowe (Szacowany)

1 stycznia 2030

Ukończenie studiów (Szacowany)

1 stycznia 2031

Daty rejestracji na studia

Pierwszy przesłany

14 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

19 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 26-1754

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

beginning 9 and continuing for 36 months following publication

Kryteria dostępu do udostępniania IPD

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj