Farzana Qureshi’s happiness over a smooth and uncomplicated pregnancy ended abruptly the day she went into labour. Tired by the end of eight hours of contractions, the 30-year-old was unable to push out her baby, whose umbilical cord was wrapped around its neck.
When the baby emerged, he was limp and bluish, and did not cry for 15 minutes. “For a while I was scared that something may go wrong with my child because of my lack of effort,” Qureshi says.
Doctors at the Indian government-run hospital gave the baby immediate resuscitation and advised admission to a neonatal intensive care unit (NICU), which, unfortunately, was at a public district hospital 37 miles away from Maheshwar, Qureshi’s hometown. Unsure of the infrastructure and availability of neonatal care equipment, her family rushed the baby to the nearest private hospital instead, which took them three hours to reach.
They were not to know, but their decision would be critical for their young son, Mudassir, who was diagnosed immediately with moderate birth asphyxia. The Seva and Samarpan (SNS) neonatal hospital in Indore is one of the few hospitals in the country to have a piece of equipment that can administer therapeutic hypothermia – the treatment for birth asphyxia – a MiraCradle.
The brain of an infant afflicted with birth asphyxia doesn’t receive sufficient oxygen before, during or immediately after birth, causing some cell damage instantly. Several obstetric problems could lead to asphyxia, including a long and difficult birth, compression of the umbilical cord, or placental insufficiency – a condition where the baby doesn’t get enough oxygen and nutrients from the mother.
The second stage of injury from asphyxia – which occurs after the brain begins receiving normal flow of oxygen – is due to toxins released from the injured cells. Depending on the degree of asphyxia and the part of the brain injured, these toxins can either cause death of the infant or extensive damage to its tissues, resulting in cerebral palsy, motor disorders, speech and developmental delays or intellectual disabilities, later in life. Therapeutic hypothermia can prevent the release of such toxins and mitigate the severity of the long-term effects of asphyxia.
Western hospitals use fully automated devices for cooling, which function by wrapping a blanket filled with chilled fluid around the patient. These machines automatically adjust to temperature fluctuations in the body, requiring very little human intervention. However, they cost 1,800,000 to 2,500,000 rupees (£21,707 to £30,140), the amount in which a hospital could purchase two ventilators, indispensable for its NICU.
More than a quarter of neonatal deaths occur in India. Nearly 28 out of 1,000 newborns in the country are reported to die within four weeks of birth, 20% of them due to birth asphyxia. But most upmarket Indian hospitals can’t buy the hypothermia-inducing machine, as they don’t get enough patients to recover costs. For low-resource facilities, which need it the most, it is unaffordable.
Studies prove that the disadvantaged sections of society – including rural and semi-urban poor – are at higher risk of birth asphyxia because of limited access to healthcare facilities in their vicinity, as was the case with Qureshi. Poor maternal health and adolescent marriage could also lead to problems during labour and greater incidence of asphyxia during birth.
How to come up with an affordable model? Dr Niranjan Thomas, professor of neonatology at Christian Medical College in Vellore, had seen hypothermia therapy work during his stints in Australia and Canada. He pioneered the use of ice packs at his hospital in India and used it to treat babies for two years. But it wasn’t a very efficient way of cooling a delicate newborn.
“Temperature drops with ice are sudden and can cause shivering and hurt a baby’s skin,” he says. Plus ice packs need to be replaced every three to four hours and medical staff has to constantly track the baby’s temperature to keep it in the desired range through external warming or cooling.
Then a study published on cooling piglets with phase changing materials (PCMs) gave him the inspiration for using them in a hypothermia-inducing device for babies. PCMs, which can be tailor made, are materials that absorb thermal energy during melting and release it during freezing, keeping a nearly constant temperature. When kept in close contact with a neonate, heat transfer occurs between the PCM and the baby’s body, until both achieve the same temperature.
Thomas worked relentlessly with Pluss Advanced Technologies Ltd, a Gurgaon-based materials research and manufacturing company, which supplied him the raw material, to perfect the device. His innovation was launched commercially in the autumn of 2014 and is now being used in more than 125 hospitals across India and three in South Africa.
MiraCradle is easy to operate. It comes with six sheets of two different kinds of PCMs, encapsulated in a plastic film for safety, and refrigerated for 8-10 hours before use. The PCM sheets need to be removed from refrigeration just 10-15 minutes before use, so the preparation time for treatment with MiraCradle is no more than a quarter of an hour, which is crucial for a therapy that has to begin within six hours of a child’s birth.
Once an infant is brought in for treatment, the physician places the sheets in the plastic insulated cradle, over which a conduction mattress is positioned to speed up the temperature exchange between the baby and the PCM. The moment the baby is laid on the mattress, the PCM begins to absorb heat from its body. In 45 minutes, the baby’s temperature stabilises between 33-34C – the requisite temperature for treatment – while the PCM maintains itself at its melting point of 28-29C for the next 72 hours, the period of therapy. Any heat that the infant produces is absorbed by the PCM to keep its temperature steady, allowing smooth treatment.
At a cost of 150,000 rupees (£1,809) and with a five-year shelf life, doctors are able to offer hypothermia therapy, at an affordable price, to patients from disadvantaged backgrounds. At 1/10th the cost and with no constant power requirement, MiraCradle has the potential to help thousands and Pluss recently won a grant from Millenium Alliance to conduct a pilot in Rajasthan.
Mudassir is now a four-month-old healthy baby, who grasps objects, gurgles and coos at his parents frequently and even smiles at strangers. So far, he has met his milestones on time. Qureshi fully understands that had her family not taken the decision of admitting him to a private hospital, which helped Mudassir receive hypothermia therapy within six hours of birth, she may not have brought him home alive.
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