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NCT Number: NCT07773350

Insecticide-Treated Baby Wraps for the Prevention of Malaria

The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children

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Key information

Age range

2 month–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

Location contact

Edgar Mulogo, PhD, MPH

CONTACT

256-48540-20332

Edgar Mulogo, PhD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Permethrin-treated lesu

Other

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

Etofenprox-treated lesu

Other

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 lesu

Other

Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. Wrap attrition

    Time frame: From enrollment through Month 24

    The number of wraps lost or damaged and requiring replacement.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  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.

  25. 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.

  26. 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.

  27. 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.

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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).

  35. 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).

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ross Boyce, MD, MSc

CONTACT

[email protected]

919-966-2537

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Mbarara University of Science and Technology
  • North Carolina State University

Registry information

Official study title

Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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