Thanks for the congratulations! It was a lot of work over many months by all members of our study team both in Toronto and in Pakistan to get our study up and running. It’s very exciting and rewarding for all of us to see that it’s finally happening.
What we have done is randomized a total of just over 600 villages and the 185 Lady Health Workers (LHW) that work in these villages to one of two groups. In both of the groups, women will be consented and enrolled into the study during their third trimester of pregnancy. The women in the intervention groups will receive the neonatal kit and the women in the control groups will receive the current level of care as delivered by the LHW program.
When the baby is born, mothers who received the kit will use the kit as they were taught by the LHW. In both the intervention and control groups, a separate group of young women called data collectors will visit each home multiple times during the first month of the newborn’s life. The job of the data collectors will be to collect all the outcome data that will help us determine if the kit works the way we think it will – to save lives by reducing and providing early identification of serious problems like infection, hypothermia, and other complications of having a low birth weight.
"The pregnant woman will be visited once during the third trimester of pregnancy to be enrolled in the study (and receive the kit if in the intervention group) and the home will be visited an additional five times in the first four weeks after delivery – on days of life 1, 3, 7, 14, and 28."
There will be a two month scale up period during which we will make sure that all of the logistics of kit delivery and data collection are running smoothly and then a full 12 months of births will be included in the final analysis of the study. Through this time, we will see running totals of major study outcomes including women enrolled, kits distributed, births, and deaths, however as investigators we will remain blinded as to which group were randomized to so as to not introduce any bias into the study. There will be a formal analysis at the midpoint of the study and then at the end of the study, groups will be unblinded and the final analysis will be conducted to determine if the kit reduced mortality.
In regards to visits during the study, the pregnant woman will be visited once during the third trimester of pregnancy to be enrolled in the study (and receive the kit if in the intervention group) and the home will be visited an additional five times in the first four weeks after delivery – on days of life 1, 3, 7, 14, and 28. We also hope to visit a subset of homes again when the child is one year old to conduct neurodevelopmental assessments. I believe that in addition to saving lives, the kit may also improve cognitive development in surviving children through reducing serious insults that occur at a particularly important time for the developing brain.
"The data collectors for the study are young women mainly in their 20’s from Rahimyar Khan. These women were previously recruited for an earlier study run by Aga Khan University in the area and were top performers during this studies which lead to their recruitment to the current neonatal kit trial."
Many low income countries use community health workers to deliver very basic health education and care to families at the community level. In Pakistan, this program is called the Lady Health Worker Program and the women receive a small salary from the government. Lady Health Workers deliver information to families regarding health pregnancy and basis aspects of newborn care and also monitor for signs of illness during their home visits. LHWs come from the communities in which they work and thus they are well known to all families in their areas. During my visits to Pakistan, I met with leaders of the LHW program and explained the purpose of the study along with the role of the LHWs. Once obtaining permission and buy in from the LHW program leaders, I met with several groups of LHWs to again explain the study and their role. It was obvious that to me that the LHWs were excited and eager to participate in a study that may prove the kit works and provide them with a new and powerful tool to save lives. In total, there will be 185 LHWs involved in the study.
The data collectors for the study are young women mainly in their 20’s from Rahimyar Khan. These women were previously recruited for an earlier study run by Aga Khan University in the area and were top performers during this studies which lead to their recruitment to the current neonatal kit trial. I’ve met and helped to train these young women and each time I meet them I’m beyond impressed with their intelligence, dedication, and hard work. It won’t come as a surprise to most readers that the educational and career options for a woman in rural Pakistan are very different from Canada, Hong Kong, and other developed countries. If born elsewhere, I don’t have a shred of doubt that all of these women would be doctors, nurses, bankers, lawyers, and other professionals. Each and every one is incredibly devoted and invested in playing a part in improving the health of their community.
"I believe that by reducing infection and severe hypothermia in newborns, we may not only save lives but also save brains."
The first few weeks of life are a critical time for brain development. During this time, new connections between different cells of the brain are made, altered, and optimized. Serious insults such as severe infection and hypothermia to the newborn during this critical time can have dramatic effects on the developing brain. The impact of these early insults may not be apparent early and only become evident later as either gross deficits such as motor dysfunction and major learning disabilities or more subtle deficits such as language or cognitive defects. In either case, early insults to developing brains can result in altered neurodevelopment and ultimately, decreased human capital. We know that children with neurodevelopmental deficits are less likely to attend and stay in school and grow into productive and contributing members of society. I believe that by reducing infection and severe hypothermia in newborns, we may not only save lives but also save brains. To test this theory we will be assessing a subset of children from both intervention and control arms of the study at 1 year of age and administer a neurodevelopmental assessment test. If the children whose mothers used the kit are shown to have higher levels of neurodevelopment than children whose mothers did not use the kit, it would be powerful new evidence and strengthen the argument for widespread use of the kit.
"We will also use results collected by the data collectors to better understand exactly how different components of the kit worked. By beginning to understand the relative contribution of different parts of the kit we may be able to tweak the kit to be more effective or less expensive, in either case, making it a better tool to save lives."
If, as we believe, the kit will save both newborn lives and brains, with ongoing support from our partners BabyHero and Maternova, we hope to scale up the use of the kits in a wider area. An unfortunate reality of global health is that there are many interventions which seem to work in a study setting but either aren’t scaled up or don’t work when used outside of the rigorous setting of a scientific study. Our goal from the beginning in designing the kit was to build a tool with the best chance of being able to be scaled up effectively. Our ultimate goal isn’t to save lives in the study (although we do believe this will be the case), but rather to save lives throughout Pakistan and other low income countries. By using Lady Health Workers rather than study workers as a means to both deliver the kit and teach mothers about its use, we are really increasing the likelihood that we can scale up from the Rahimyar Khan area. The Lady Health Worker program exists throughout the country (and similar programs run in other low income countries) meaning the delivery mechanism for the intervention is already in place nation-wide.
We will also use results collected by the data collectors to better understand exactly how different components of the kit worked. By beginning to understand the relative contribution of different parts of the kit we may be able to tweak the kit to be more effective or less expensive, in either case, making it a better tool to save lives.