Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Insecticide-Treated Baby Wraps for the Prevention of Malaria

14. srpna 2026 aktualizováno: 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

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

1296

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Uganda
      • Mbarara, Uganda
        • Mbarara University of Science and Technology
        • Kontakt:
          • Edgar Mulogo, PhD, MPH
          • Telefonní číslo: 256-48540-20332
        • Vrchní vyšetřovatel:
          • Edgar Mulogo, PhD, MPH

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
Jiný: 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
Experimentální: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
Jiný: 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
Falešný srovnávač: Receives non-treated lesu
Receives the non-treated lesu for 2 years
Jiný: Untreated lesu
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of clinical malaria in children between the etofenprox and control arms
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence of clinical malaria in children between the permethrin and control arms per site
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of North Carolina, Chapel Hill

Spolupracovníci

Mbarara University of Science and Technology
North Carolina State University

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. ledna 2027

Primární dokončení (Odhadovaný)

1. ledna 2030

Dokončení studie (Odhadovaný)

1. ledna 2031

Termíny zápisu do studia

První předloženo

14. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

14. srpna 2026

První zveřejněno (Aktuální)

19. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 26-1754

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

beginning 9 and continuing for 36 months following publication

Kritéria přístupu pro sdílení IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit