An interventional study of Permethrin-treated lesu and Etofenprox-treated lesu in Malaria (Plasmodium Falciparum) and Malaria Incidence, sponsored by University of North Carolina, Chapel Hill. Not yet recruiting at 1 site in Uganda. Open to participants aged 2 Months to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
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.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 1,296 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives permethrin-treated lesu for 2 years
Other: Permethrin-treated lesu
Receives etofenprox-treated lesu for 2 years
Other: Etofenprox-treated lesu
Receives the non-treated lesu for 2 years
Other: Untreated 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
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
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
Incidence of clinical malaria in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Incidence of clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Incidence of clinical malaria in children between the permethrin and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Incidence of clinical malaria in children between the etofenprox and control arms per site
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Incidence of hospitalizations due to malaria between the permethrin and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Time frame: From enrollment to Month 36
Incidence of hospitalizations due to malaria between the etofenprox and control arms
Incidence of admissions from clinic after a positive malaria RDT.
Time frame: From enrollment to Month 36
Number of deaths from any cause between the permethrin and control arms during wrap use
Number of deaths documented, regardless of cause.
Time frame: From enrollment to Month 24
Number of deaths from any cause between the etofenprox and control arms during wrap use
Number of deaths documented, regardless of cause.
Time frame: From enrollment to Month 24
Number of deaths from any cause between the permethrin and control arms after wrap use has been discontinued
Number of deaths documented, regardless of cause.
Time frame: From Month 24 to Month 36
Number of deaths from any cause between the etofenprox and control arms after wrap use has been discontinued
Number of deaths documented, regardless of cause.
Time frame: From Month 24 to Month 36
Number of deaths from malaria between the permethrin and control arms during wrap use
Number of deaths documented during hospitalization.
Time frame: From enrollment to Month 24
Number of deaths from malaria between the etofenprox and control arms during wrap use
Number of deaths documented during hospitalization.
Time frame: From enrollment to Month 24
Number of deaths from malaria between the permethrin and control arms after wrap use has been discontinued
Number of deaths documented during hospitalization.
Time frame: From Month 24 to Month 36
Number of deaths from malaria between the etofenprox and control arms after wrap use has been discontinued
Number of deaths documented during hospitalization.
Time frame: From Month 24 to Month 36
Difference between the permethrin and control arms in change from baseline of childrens' hemoglobin levels
Hemoglobin measured using a Hemocue device.
Time frame: At baseline, 12 Months, and 24 Months
Difference between the etofenprox and control arms in change from baseline of childrens' hemoglobin levels
Hemoglobin measured using a Hemocue device.
Time frame: At baseline, 12 Months, and 24 Months
Incidence of non-malarial febrile episodes in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Incidence of non-malarial febrile episodes in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness and negative malaria RDT at a scheduled or unscheduled study visit.
Time frame: From enrollment through Month 24
Wrap attrition
The number of wraps lost or damaged and requiring replacement.
Time frame: From enrollment through Month 24
Incidence of rebound clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
Time frame: From Month 24 through Month 36
Incidence of rebound clinical malaria in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit after wrap discontinuation.
Time frame: From Month 24 through Month 36
Number of adverse reactions to wraps between the permethrin and control arms
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
Time frame: From enrollment through Month 24
Number of adverse reactions to wraps between the etofenprox and control arms
Counts of the top 5 most common adverse reactions reported by participants on questionnaires and assessed by clinic staff.
Time frame: From enrollment through Month 24
Number of participants with care-seeking events attributable to the permethrin wrap versus the control
Number of participants with care-seeking events attributable to the permethrin wrap versus the control wrap.
Time frame: From enrollment through Month 24
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control
Number of participants with care-seeking events attributable to the etofenprox wrap versus the control wrap.
Time frame: From enrollment through Month 24
Number of participants with hospitalizations attributable to the permethrin wrap versus the control
Number of participants with hospitalizations attributable to the permethrin wrap versus the control wrap.
Time frame: From enrollment through Month 24
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control
Number of participants with hospitalizations attributable to the etofenprox wrap versus the control wrap.
Time frame: From enrollment through Month 24
Number of participants with death attributable to the permethrin wrap versus the control
Number of participants with death attributable to the permethrin wrap versus the control wrap.
Time frame: From enrollment through Month 24
Number of participants with death attributable to the etofenprox wrap versus the control
Number of participants with death attributable to the etofenprox wrap versus the control wrap.
Time frame: From enrollment through Month 24
Change in child's height-for-weight between the permethrin and control arms
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
Time frame: From enrollment through Month 24
Change in child's height-for-weight between the etofenprox and control arms
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
Time frame: From enrollment through Month 24
Change in child's height-for-age between the permethrin and control arms
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
Time frame: From enrollment through Month 24
Change in child's height-for-age between the etofenprox and control arms
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
Time frame: From enrollment through Month 24
Change in child's weight-for-age between the permethrin and control arms
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
Time frame: From enrollment through Month 24
Change in child's weight-for-age between the etofenprox and control arms
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
Time frame: From enrollment through Month 24
Change in child's acute malnutrition between the permethrin and control arms
Change in Mid-upper arm circumference (MUAC).
Time frame: From enrollment through Month 24
Change in child's acute malnutrition between the etofenprox and control arms
Change in Mid-upper arm circumference (MUAC).
Time frame: From enrollment through Month 24
Change in child's score on the Mullen Scales of Early Learning between the permethrin and control arms
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Enrollment, Year 1, Year 2, Year 3
Plan to share: Yes — 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.
Time frame: beginning 9 and continuing for 36 months following publication
Access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
Of 24 interventional studies with no phase under Malaria, Falciparum, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
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