Clinical Trials

Largest known clinical trial of an infant warmer designed for and tested in a low resource setting

The DreamWarmer has now been tested over 1,000 times in district hospitals and health centers throughout Rwanda over the course of three clinical trials.

Between 2016 and 2020 two pilot studies and one large-scale randomized controlled trial were conducted in Rwanda to assess the safety, effectiveness, and usability of the DreamWarmer.

    Combined data from the three clinical trials:

    • No adverse effect such as rashes or burns
    • Babies became or stayed warm in 92% of uses
    • 100% correct preparation, use, and cleaning
    • Overwhelmingly positive feedback from mothers and nurses in qualitative interviews

    Pivotal Trial

    The DreamWarmer was tested across 10 hospitals in Rwanda in 2020. 3179 patients were enrolled of whom 464 used the warmer a total of 892 times by babies who were hypothermic or at risk for hypothermia because of low birthweight (< 2.5 kg) when KMC was not available. The rate of euthermia rose from 51% before to 67% after the introduction of the warmer. Of those who used the warmer, only 11% remained hypothermic, and the mortality rate dropped from 2.8 to 0.9%. The results have been published in the Lancet’s EClinical Medicine (we will have link by the end of the week) 

    Pilot studies, Phase 1 and 2

    In a two pilots studies, the warmer was tested a total of 204 times in Rwandan hospitals and health clinics. Babies were eligible to use the warmer if they were hypothermic or at risk for hypothermia because of low birth weight (< 2.5 kg) when KMC was not available. In 98% of uses, hypothermia was prevented or corrected.

    Qualitative Results are overwhelmingly positive:

    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

    For me, I found that the warmer doesn’t cause any problem, it is a very good thing. Maybe you should see how you can supply the warmers to all health facilities and health posts, just everywhere so that new babies can be warmed up.

    Caregiver

    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.

    Caregiver


    When you put the infant on a warmer, who was in post-partum care crying and not breastfeeding. The infant starts to breastfeed and stop crying immediately. It is an amazing thing because mothers did not know what to do.
    Rwandan Nurse

    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

    For me, I found that the warmer doesn’t cause any problem, it is a very good thing. Maybe you should see how you can supply the warmers to all health facilities and health posts, just everywhere so that new babies can be warmed up..

    Caregiver

    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.

    Caregiver

    When you put the infant on a warmer, who was in post-partum care crying and not breastfeeding. The infant starts to breastfeed and stop crying immediately. It is an amazing thing because mothers did not know what to do.

    Rwandam Nurse

    DreamWarmer’s mattress in partially melted phase (extra long prototype used in early testing).

    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. 

    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. During qualitative interviews, we received overwhelmingly positive feedback from mothers and nurses.

    Current Testing

    Based on encouraging results from our pilot field studies, we conducted a Stepped Wedge randomized controlled clinical trial that we completed in July 2020. With this clinical trial, each hospital served as its own control:

    The control data was collected during an initial pre-intervention period for each hospital. During this time, hospitals provided current standards-of-care based on the Rwandan National Neonatal Protocols, with STS offered for infants who met certain criteria based on the degree of prematurity, body weight and temperature. Data was also collected for vital signs, rate of growth, length of hospital stay and mortality. A district hospital was then added at regular intervals (steps), at which time the DreamWarmer™ was introduced, moving that hospital from the control arm to the treatment arm (DreamWarmer™). Gradually, all study hospitals will move from the control arm to the treatment arm over an approximate six-month period.