Round 3 Innovators

Devastating brain injury and neonatal death caused by hyperbilirubinemia (kernicterus) is very common in low resource settings (LRS) but can be prevented by early detection and treatment with light therapy. A major roadblock to the global effort to eliminate kernicterus is the inability to measure total plasma bilirubin (TB) in most LRS, including many referral hospital centers. To meet this need, we are developing an inexpensive POC system that rapidly measures TB. A small drop of blood (ca.

Preeclampsia is a major cause of maternal and neonatal death, particularly in low-income and developing countries. When treated properly the mortality rate is low. Unfortunately many women in low-income countries do not have ready access to proper care. Our research has shown that we can reliably detect preeclampsia 10-12 weeks before the onset of symptoms. We propose to create an inexpensive, easy-to-use, handheld system that detects the likelihood of the future onset of preeclampsia. A 50-patient clinical study will validate its effectiveness.

The transmission of HIV from mother to child during the birthing process can be largely prevented by the administration of ARV drugs. But, the newborn must start receiving medication within 24 hours after birth to be most effective. In Zambia, only 22.1% of infants born at home to HIV+ mothers receive the medication they need because it is difficult to get the medicine to them.

Guatemala has one of the highest national maternal mortality ratios in Latin America at 149 per 100,000 live births, and up to 260 per 100,000 in some northern departments. Only 31% of deliveries are attended by a skilled birth attendant. Since early 2004 Guatemala has invested heavily in building and updating northern clinics for 24 hour delivery care. It was expected that as access increased, rates of maternal and perinatal mortality would drop. But as of 2012 this had not occurred.

Globally 814,000 neonatal deaths result from intrapartum birth asphyxia in term babies and 1.03 million from complications of prematurity (WHO/ UNICEF 2010). Effective resuscitation could reduce intrapartum related neonatal deaths by 30%, and deaths from prematurity by 10%, creating potential to save 347,200 babies annually. However, one in five trained healthcare professionals (HCPs) fail to perform the resuscitation technique correctly, and those that do, often experience a rapid decline in proficiency (Patel J et al 2012).

Postpartum hemorrhage (PPH) is the leading cause of maternal mortality in low-income countries. The majority of these deaths occur outside the health care system, and so an intervention that could be used in any setting and with minimal training could save lives. We will use an animal model to demonstrate appropriate uterine fill, and a proof-of-concept study to show stoppage of post-delivery bleeding and test ease of removal.

Nearly half of all infant deaths occur in the first 28 days after birth, with intrauterine growth restriction, prematurity, low birth weight, hypothermia, and sepsis as leading causes. Rapid and reliable identification of frail and sick newborns is critical to saving lives. Current algorithms used by community health workers for integrated management of neonatal and child illness can identify up to 50% of frail newborns. However, this leaves 50% undetected even under ideal conditions of worker quality and performance. Improved ability to detect IUGR and frail and sick newborns is needed.

Preeclampsia and eclampsia (PE/E) are the second leading causes of maternal deaths and disability in developing countries, affecting thousands of pregnant women and their newborns each year. Magnesium sulfate (MgSO4) is considered the most effective, safe, and low-cost treatment for PE/E. Yet, MgSO4 continues to be greatly underutilized, especially in peripheral facilities, where the majority of women at high-risk deliver.

In limited-resource settings, morbidity and mortality from preeclampsia results from lack of/delayed diagnosis. Preeclampsia is a hypertensive proteinuric syndrome unique to human pregnancy. The problem is that neither hypertension nor proteinuria is sensitive or specific, especially in women with atypical presentations. We provided novel evidence that the urine of preeclamptic women is highly enriched in misfolded proteins. Based on this, we developed the Congo Red Dot (CRD) as a diagnostic and clinical prognostic tool for preeclampsia.

New drug delivery methods for infants are needed in low- and middle-income countries. Each year over three million babies die within the first month after birth, with the risk of death highest during the initial hours and days. Most of these deaths are easily preventable by early administration of drugs or nutrients [WHO/PMNCH "Millennium Development Goal 4" Fact Sheet, 2011]. We propose to develop a low-cost Nipple Shield Delivery System (NSDS) to administer drugs or nutrients to breastfeeding infants via easily disintegrating tablets within a modified nipple shield.