Product/Service Development

Continuous positive airway pressure (CPAP) therapy is the standard of care for treatment of neonatal respiratory distress, but the availability of CPAP devices is limited by cost and facility infrastructure such as electricity and pressurized air. The bubble CPAP (bCPAP) kit and oxygen blender address the lack of electricity and pressurized air, common in rural health clinics, and have been demonstrated to provide a stable supply of blended gas.

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. A wide-range of active pharmaceutical ingredients (APIs) could be delivered to infants using the NSDS such as antibiotics, antimalarials, antiretrovirals, vitamins, nutrients, and probiotics. Use of the NSDS would empower a breastfeeding mother during the early postnatal period by allowing her to personally administer medicines in a natural setting.

Effective resuscitation could reduce intrapartum related neonatal deaths by 30%, and deaths from prematurity by 10%, creating the 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. Our Augmented Infant Resuscitator's advanced training capabilities, instant feedback mechanism, and objective self-audit and retraining abilities will maximize and sustain gains from effective resuscitation.

Injectable oxytocin has been recommended by the World Health Organization for routine use in prevention and treatment of Postpartum hemorrhage (PPH). However, safely delivering an injection requires a trained provider and sterile equipment, ideally in a health facility setting. Additionally, delivering a lifesaving dose of oxytocin is further complicated by the poor stability of oxytocin - it is inactivated if exposed to high ambient temperatures.

We propose to design a gel formulation for sustained release of sulfate (MgSO4) via the rectal route of administration. We will carry out preclinical studies to determine the pharmacokinetics and efficacy of rectal administration of the novel MgSO4 formulation. We will also conduct a user assessment study in Western Kenya among health providers to evaluate the acceptability and feasibility of introducing a rectal delivery method for Preeclampsia and eclampsia.

Population Services International (PSI) proposes to conduct a proof-of-concept study followed by a larger clinical trial in two public sector hospitals through FOGSI in India, to determine if a new intrauterine device (IUD) inserter, specifically designed for the postpartum setting, will improve service delivery. Pregna International will provide the inserters free of cost, and Stanford University will provide technical expertise in study design and implementation.

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. Standard care for treating PPH consists of massage, uterotonics, and tamponade (i.e., "holding pressure").

We propose to roll out and evaluate a next-generation uterine balloon tamponade (UBT) device to arrest maternal hemorrhage in Kenya and Sierra Leone, where maternal mortality statistics are alarmingly high. We will deploy UBT as part of a best-evidence package of training, commodities, and checklists related to the treatment of PPH. We have established strong proof of concept for our package in these countries. The UBT system will also include cutting-edge cell phone technology that will facilitate UBT referral tracking and documentation of patient outcomes.

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.

This project proposes to develop a rectal formulation of a third-generation cephalosporin antibiotic for reducing mortality through early community-based management of neonatal sepsis. It will carry out pharmaceutical and preclinical studies with the aim of developing a stable rectal formulation of a candidate antibiotic with adequate bioavailability. Selection will depend on activity against causative pathogens, a good safety profile, and central nervous system penetration. Rectal administration is a simple, safe, and acceptable method of treating sick children.