Laura Seehausen's question for Amnion Life™
The neonate’s in your incubator don’t appear to have any boundaries. As a NICU nurse, this concerns me. Being at the bedside, we see a direct correlation in stable vital signs and lower oxygen needs when our infants are positioned correctly. They are more comfortable, they sleep better, and their weight gain is improved. I even personally feel like it aids in digestion, as I see less reflux and residuals when my infant is calm and contained. We use a z-flow pad and tube to position all our micropreemies; this keeps their position as close to the womb as possible while also providing them a boundary to push and kick against. How will we provide boundaries for an infant surrounded by fluid?
Of course I am also wondering how we will safely secure umbilical lines, PICC lines, peripheral IVs, and PALs, and then also be able to position that limb correctly to provide comfort and security to the baby.
What about kangaroo care? We start kangaroo care on day five of life, even in a 23 weeker who is intubated, if they are stable enough. What will be the ramifications of an infant having to be removed from that environment possibly one or more times daily? Will there be a way to weigh the infant each day without draining the fluid? How will we maintain temperature stability if we are constantly draining and re-filling the fluid?
Amir Fassihi MD answers:
Thank you for your thoughtful and expert questions. These are matters which have preoccupied our research and thought for three years and I am glad you are addressing it as well.
As far as positioning of the infant, we are currently working on an ergonomic comfortable seat with special head rests made for the infants. We are currently trying to do some R&D on adjustable head and neck rest so that a nurse can adjust the head and neck rest similar to a car seat. However, please note that the current design will likely be significantly changed and redone as we progress through usability studies and clinical trials. We are currently projecting a pilot study of 5-10 infants for a maximum of 60 minute bath. We will learn many things from such a trial. However, we have a long way to go with usability testing of the device by nurses (without an infant) followed by potential animal studies before we can do the final design of the seat and neck/headrest. (see photos below on head positioning)
Regarding your question about fetal in-womb push against amniotic sac which aids in bone development, this is also something we've taken into consideration. Our challenge in this regard is similar to the current incubator technology. In the current incubators, the infants also don't have the natural amniotic sac to push against which aids in musculoskeletal development. What we've considered is a slightly heavy see-through plastic cover on the infant which can simulate the pressure and comfort of the amniotic sac. But since our initial trials will be in 60 minute or later on on less than 24 hour stays, we are going to tackle that issue when we further design the device for longer AmnioBed stays of >24 hours.
Regarding your concerns about central lines and PICC lines, this is perhaps our most important challenge and something we've done significant work on. This is a very important point you have raised. Please refer to Dr Hardy's questions on our website under FAQ. In addition, photos of how we will attach IV lines via the umbilical cord can be found under the section: Updates From Our Research Facility.
Regarding Kangaroo care, our device will have the same restrictions for removal from the incubator as the current convection incubators. Infants can be removed for kangaroo care and placed back into the incubator at any time if kangaroo care is deemed safe by the nurse and medical staff.
Regarding nursing consultants, that is on our wish list at the moment for the company, but we are limited on funds and still early in the product development. I've had the opportunity to discuss our concerns and seek input from NICU nurses unofficially, but with the limited budget we've had, we decided that we need expert neonatologists first to make sure all medical needs and concerns are addressed prior to working on the details of the nursing requirements and needs such as positioning and device everyday usability and ease of use.
Hope I got all your questions addressed. Thank you for your insightful questions.
