Field Proven

Tested 204 Times in District Hospitals and Health Centers throughout Rwanda

• 98% infants achieved or maintained normal temperature
• 100% correct preparation, use, and cleaning of warmer despite short training
• No adverse effects except 3% instances of mild hyperthermia
• Overwhelmingly positive feedback from mothers and nurses in qualitative interviews

 

DreamWarmer Demo

Watch our Demo on Open Pediatrics

In this video, Dr. Anne Hansen, Medical Director of the Neonatal ICU at Boston Children’s Hospital, outlines challenges facing today’s physicians and nurses in Rwanda as they care for newborns. She also introduces the DreamWarmer and outlines the benefits of its use in dealing with the challenge of neonatal hypothermia.

Phase 1

The warmer was tested 102 times for babies who were hypothermic or at risk for hypothermia because of low birth weight (< 2.5 kg) in two district hospitals in Rwanda. In 98% of uses, hypothermia was prevented or corrected and there were no adverse effects except seven instances of mild hyperthermia. There were no instances of incorrect preparation, use or cleaning despite only a short training period. We received overwhelmingly positive feedback from mothers and nurses.

Phase 2

We have recently completed use of the warmer an additional 102 times in the health center setting in Rwanda, along with qualitative interviews of nurses and mothers regarding their opinions of the warmers and its relationship with STS. There was only one instance of mild hyperthermia (37.7 °C) that resolved despite the infant remaining on the warmer. Of 81 hypothermic infants placed on the warmer, 79 became euthermic. Again there were no instances of incorrect use.

Qualitative Results are overwhelmingly positive:

“There is nothing else I can add except for thanking you who have brought this infant warmer, because it has helped me. I don’t even know how my baby would get warm had you not given me the warmer.”

– Rwandan Caregiver

“When you measure infants’ temperature and you find that they are cold, you can give one to each infant and then where you are in your job you can feel confident that your infants are warm.”

– Rwandan Nurse

“There is a case where a mother delivers a baby and she does not have a maid. After giving birth, she finds her alone to treat herself and baby. She thinks how to carry the baby, clean materials, wash herself and the baby, and finally, all these issues bring the challenges. But if it was this infant warmer, she would put the baby on it and deal with the rest.”

– Rwandan Nurse

Future Testing

Based on the encouraging results from our pilot field studies, we are now designing a step-wedge cluster randomized controlled clinical trial. With this trial design, each hospital will serve as its own control: The control data is collected during an initial pre-intervention period for each hospital. During this time, hospitals will provide the current standard of care based on the Rwandan National Neonatal Protocols, with STS offered for infants who meet certain criteria based on degree of prematurity, body weight and temperature, while collecting data regarding vital signs, rate of growth, length of hospital stay and mortality statistics. A randomized cluster of hospitals will then be added at regular intervals (steps) at which time the infant warmer will be introduced and that cluster will move from the control arm to the treatment arm (with the treatment being the provision of the DreamWarmer). Gradually all of the study hospitals will move from the control arm to treatment arm over an approximate six-month period.

This design is intended to provide increased statistical power relative to a standard randomized controlled trial due to repeated observations and a lower intra-cluster coefficient. Furthermore, this design helps to sidestep the ethical issue of randomly choosing a sample of hypothermic infants as a control group who are offered a lesser level of care than another infant in the same hospital at the same time. Finally, this design allows for efficiency of staffing as only a subset of “cluster” hospitals needs training at any one time.