After months of preliminary research and training, the Neonatal Kits that Baby Hero funds are now being delivered to expectant mothers in the Rahim Yar Khan district of Pakistan, and the medical study to ascertain its effectiveness is underway.
In this district, roughly 700 kilometers northeast of Karachi, more than half of all women give birth at home, and 42 out of every 1,000 newborns do not survive their first 28 days of life. This low-cost, low-tech, Ziplock-sized kit, developed by Dr. Shaun Morris -- a pediatric infectious disease specialist at the Hospital for Sick Children (SickKids) and scientist and principal investigator at SickKids Center for Global Child Health in Toronto -- aims to reduce infant mortality in this region by 30-40 percent. Dr. Morris answers questions on the study, the crucial role of lady health workers and how these kits will not only save lives but also save brains.
1. Can you share the study methodology -- what's going on in the field, how many villages are covered and how many mothers will receive the kits?
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.
2. What is the timeline for the study and when will the results start to roll in?
There will be a two-month scale up period during which we will make sure all 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. 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 groups were randomized so as not to 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.
Pregnant mothers 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 neurodevelopment 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.
3. We have heard that the field workers -- the Lady Health Workers and Data Collectors -- are crucial to the success of the study. Tell us more.
Many low-income countries use community health workers to deliver basic health education and care to families at the community level. In Pakistan, this program called the 'Lady Health Worker Program' delivers information to families regarding health, pregnancy and basis aspects of newborn care, and monitor for signs of illness during their home visits. LHWs come from the communities in which they work and thus are well known to all families in these areas. During my visits to Pakistan, I met with leaders of the LHW program and they are eager to participate in a study that may prove the kit works, and will provide them with a new and powerful tool to save lives in their community. In total, there will be 185 LHWs involved in the study.
The data collectors for the study are young women in their twenties from Rahim Yar Khan. These women were previously recruited for an earlier study run by Aga Khan University in the area. Top performers from this study were recruited for the current Neonatal Kit trial. I've met and helped to train these young women and I'm so impressed with their intelligence, dedication, and hard work. 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 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.
4. This study is not only meant to save lives, but save brains. Can you explain this correlation?
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 one 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 to strengthen the argument for widespread use of the kit.
5. How do you plan to use the results and will the kit be tweaked in any way?
If, as we believe, the kit will save both newborn lives and brains, with ongoing support from our partners Baby Hero 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 to scale 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 increasing the likelihood to scale up from the Rahim Yar 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.
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.
About Sick Kids:
SickKids Center for Global Child Health is dedicated to improving the lives of children and their families in resource-poor environments through collaboration in groundbreaking research, sustainable capacity building through education, the active communication of results through advocacy, and through promoting improved child health through knowledge and networks.
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