New malaria policies to protect early brain development

In this project

Organization:

University Health Network

Country of Implementation:

Malawi

Sites:

Mpemba, Chikwawa

Rural/Urban:

Rural

Target Beneficiary:

Pregnant Women; -9 to 0 Months; 0-2 Years

Delivery Intermediaries:

Medical Professional

Objective:

Evaluation of a novel antenatal care intervention to reduce malaria in pregnancy and improve neurocognitive development.

Innovation Description:

Novel antenatal care policy that focuses resources on accurate point-of-care malaria diagnosis and effective case- management of infection.

Stage of Innovation:

Proof of Concept

New malaria policies to protect early brain development

Organization

University Health Network

Sites

Mpemba, Chikwawa

Rural/Urban

Rural

Target Beneficiary

Pregnant Women; -9 to 0 Months; 0-2 Years

Delivery Intermediaries

Medical Professional

Objective

Evaluation of a novel antenatal care intervention to reduce malaria in pregnancy and improve neurocognitive development.

Innovation Description

Novel antenatal care policy that focuses resources on accurate point-of-care malaria diagnosis and effective case- management of infection.

Stage of Innovation

Proof of Concept

Innovation Summary

UHN logo TaglineEach year, about 125 million pregnant women are at risk of contracting malaria in pregnancy, with approximately 25% of all pregnancies in sub-Saharan Africa complicated by maternal malaria infection at delivery. Pregnancy-associated malaria has profound maternal and fetal health consequences, including increased risk of anemia, preterm birth, fetal growth restriction, delivery of low birth weight infants and impaired neurocognitive development – a consequence which is now increasingly being recognized.

This new project involves a novel antenatal care policy that focuses resources on accurate point-of-care malaria diagnosis and effective case- management of infection to reduce the burden of malaria in pregnancy and protect early brain development. This approach is called scheduled intermittent screening and treatment (ISTp).

The project team will:

  1. Compare  ISTp to current practice in terms of prevention of adverse birth outcomes and of placental malaria at birth.
  2. Evaluate the link between neurocognitive injury and pregnancy-associated malaria.
  3. Understand whether intermittent screening and treatment better protects early brain development and ameliorates the risk of malaria infection in early childhood is…
  4. Evaluate whether this intervention confers a neurocognitive developmental advantage in early childhood.

Impact

  • 400 children born to mothers enrolled in a clinical trial to evaluate different malaria prevention policies in pregnancy will be evaluated for neurocognitive development.
  • Of these, 200 mothers will receive the new intervention and 200 will receive intermittent preventive treatment.
  • 4 nurses will be trained to track the developmental outcomes of children enrolled in the birth cohort.

Malaria exposure in the womb “may derail the developmental trajectory of generations of children.
-- Dr. Kevin Kain, co-PI of project

Innovation

To combat malaria in pregnancy in sub-Saharan Africa, where Plasmodium falciparum malaria is most common, WHO policy advocates for a three-pronged approach involving 1) distribution of insecticide treated bed nets, 2) active case management and 3) intermittent preventive treatment (IPTp) with SP (sulfadoxine-pyrimethamine) for all pregnant women. However, increasing SP resistance by the malaria parasite is reducing the effectiveness of IPTp, resulting in persistent infections, and threatening the success of this program. The innovation, called scheduled intermittent screening and treatment (ISTp), is a new approach to reducing the burden of malaria in pregnancy and early childhood. This involves a novel antenatal care policy that focuses on accurate point-of-care malaria diagnosis and effective case- management of infection. The concept of ISTp is to provide scheduled screening for malaria using a malaria rapid diagnostic test (mRDT) and to treat mRDT-positive women with a long acting ACT, with the aim of clearing existing infections and providing additional post-treatment prophylaxis for three to six weeks. Screening ensures that only pregnant women who test positive for malaria parasites receive treatment, and women —  and their fetuses,  — without evidence of malaria are not unnecessarily exposed to antimalarial drugs.

ISTp is delivered as part of ‘focused antenatal care’. Women are screened for malaria and potentially treated at least three times during the second and third trimesters of pregnancy. There is now some evidence that ISTp may be an effective strategy for some parts of Africa. [1] Equally importantly, ISTp has been shown to be well-received by pregnant women and was manageable within a busy antenatal clinic. Recently, there has been increasing interest in ISTp as a potential future strategy to replace IPTp-SP in areas where SP resistance is decreasing the effectiveness of IPTp or in areas with marked reduction in malaria transmission. The impact of ISTp on neurocognitive development in early childhood has not been evaluated but has important implications for the consequent cognitive capital in malaria endemic regions. This is an important issue in light of the potential impact of ISTp on in-utero malaria exposure, ex-utero risk of clinical malaria and neurocognitive development. The project team is following a subset of children and will evaluate their neurocognitive development from 1-2 years of age, to examine the impact of in-utero malaria exposure on their development. This will allow the team to determine whether ISTp better protects early brain development.

Collaboration

Funders

Key Partners

Evaluation Methods

The project will use a randomized control trial to evaluate the suitability of ISTp as a policy to protect early brain development. Child development will be comprehensively assessed in 400 infants at 12, 18 and 24 months of age by trained nurses. Of the 400 children assessed, approximately 200 mothers will have received the intermittent preventive treatment, and the other 200 mothers will have received the new intervention.  Children will have additional follow-up visits every six months until the age of 24 months. At each visit, the overall health of the child will be assessed, with particular attention to previous or current illnesses including clinical malaria. In the absence of any illness, a battery of neurocognitive assessments will be administered to the child that evaluates motor, language and social skills. Additional assessments are conducted to evaluate the child’s higher cognitive function at 18 and 24 months of age.

References

  1. O. ter Kuile, F. et al. (2008). Optimisation of the existing dose and regimen of intermittent preventive treatment with sulfadoxinepyrimethamine. European & Developing Countries Clinical Trials Partnership. 17 Dec. 2008.
  2. Tagbor H. et al. (2010) Intermittent screening and treatment versus intermittent preventive treatment of malaria in pregnancy: a randomised controlled non-inferiority trial.

Resources

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