Insecticide-Treated Baby Wraps for the Prevention of Malaria

August 14, 2026 updated by: 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1296

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Uganda
      • Mbarara, Uganda
        • Mbarara University of Science and Technology
        • Contact:
          • Edgar Mulogo, PhD, MPH
          • Phone Number: 256-48540-20332
        • Principal Investigator:
          • Edgar Mulogo, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Mother is at least 18 years old
  • Mother has access to a working phone with a known number
  • Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age
  • Has the ability to travel to a designated study site for visits and evaluation
  • Mother/Infant pair presents to their 10-week immunization visit at one of the designated study sites

Exclusion Criteria:

  • Participation in another study of malaria prevention
  • Known allergic reaction to permethrin or etofenprox
  • Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Receives permethrin-treated lesu
Receives permethrin-treated lesu for 2 years
Other: 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
Experimental: Receives etofenprox-treated lesu
Receives etofenprox-treated lesu for 2 years
Other: 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 Comparator: Receives non-treated lesu
Receives the non-treated lesu for 2 years
Other: Untreated lesu
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of clinical malaria in children between the etofenprox and control arms
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of clinical malaria in children between the permethrin and control arms per site
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mbarara University of Science and Technology
North Carolina State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ross Boyce, MD, MSc, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-1754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

beginning 9 and continuing for 36 months following publication

IPD Sharing Access Criteria

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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