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Insecticide-Treated Baby Wraps for the Prevention of Malaria

14. august 2026 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

1296

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Uganda
      • Mbarara, Uganda
        • Mbarara University of Science and Technology
        • Ta kontakt med:
          • Edgar Mulogo, PhD, MPH
          • Telefonnummer: 256-48540-20332
        • Hovedetterforsker:
          • Edgar Mulogo, PhD, MPH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
Annen: 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
Eksperimentell: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
Annen: 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
Sham-komparator: Receives non-treated lesu
Receives the non-treated lesu for 2 years
Annen: Untreated lesu
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of North Carolina, Chapel Hill

Samarbeidspartnere

Mbarara University of Science and Technology
North Carolina State University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

1. januar 2030

Studiet fullført (Antatt)

1. januar 2031

Datoer for studieregistrering

Først innsendt

14. august 2026

Først innsendt som oppfylte QC-kriteriene

14. august 2026

Først lagt ut (Faktiske)

19. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-1754

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere