Brief Summary

Each year, \~85.3 million pregnant women are at risk of becoming infected with Plasmodium falciparum(1). Among women in sub-Saharan Africa, most of whom have some degree of clinical immunity to malaria, malaria infection in pregnancy leads to placental malaria (PM), often without clinical symptoms in the mother. The systemic and placental changes that occur with malaria in pregnancy can adversely affect the developing fetal brain, an fetal brain injury strongly affects long-term childhood neurodevelopmental (ND) and behavior but there are no published studies to date on the impact of malaria in pregnancy on childhood ND. This study, conducted in Uganda, will address the effects of malaria in pregnancy and childhood ND and define mechanisms by which malaria may lead to ND impairment including micronutrient deficiencies. ND outcomes will be measured by the following neuropsychological and behavioral tests: Mullen Scales of Early Learning, the Color Object Association Test, the Early Childhood Vigilance Test, the Behavior Rating Scales, the Behavior Related inventory of Executive Function and the Child Behavior Checklist. These tests will be given at 12, 24, 36, and 60 months of age. This study will be nested in an ongoing Ugandan IRB approved interventional trial (PROMOTE-II) (NCT02163447). Blood sampling is being conducted in the PROMOTE-II protocol for research purposes. Some of that blood will be used to test for micronutrient deficiencies as well as other immune responses to malaria.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

272

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.8 years study duration

First Submitted

Initial submission to the registry

September 21, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed

8 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2021

Completed

Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

5.8 years

First QC Date

September 21, 2015

Last Update Submit

August 23, 2021

Conditions

Neurobehavioral Manifestations

Keywords

malariainfantpregnancyprophylaxisdihyroartemisinin-piperaquinesulfadoxine-pyrimethaminebehaviorneurodevelopmentcognitive

Outcome Measures

Primary Outcomes (8)

Z-scores for Overall cognitive ability
12 months of age
Z-scores for Overall cognitive ability
24 months of age
Z-scores for Overall cognitive ability
36 months of age
Z scores for Elicited Imitation
12 months of age
Z scores for Elicited Imitation
24 months of age
Z scores for Elicited Imitation
36 months of age
Z scores of Overal Cognitive ability
60 months of age
Z scores of Elicited Imitation
60 months of age

Secondary Outcomes (3)

Z scores for Behavioral Rating Scale
24, 36, and 60 months of age
Z scores for Behavior Related Inventory of Executive Function (BRIEF)
24, 36, and 60 months of age
Z scores for Child Behavior Checklist (CBCL)
24, 36, and 60 months of age

Study Arms (5)

Maternal SP/Child 3mo DP

In this group in the PROMOTE-II study, mothers receive 3 doses of sulfadoxine-pyrimethamine (SP), and children receive every 3 month dihydroartemisinin-piperaquine (DP). No intervention is given in the observational PROTECT study.