Pilot Clinical Assessment of Low-cost Infant Incubator in Monitoring Temperature and Treating Hypothermia in Infants

This is a two-phase, pilot prospective study to determine the effectiveness of a low-cost incubator in warming infants and regulating their temperatures. The temperature sensor that controls the heat of the incubator based on the infant's temperature has been previously evaluated in Rice IRB approved studies in Houston, TX with plans to evaluate at QECH. The first phase will validate the use of the temperature sensor in infants by comparing it to a commercial temperature monitor. The second phase will test the effectiveness of the IncuBaby device using that temperature sensor to regulate the heat of the infant.

Treatment and Monitoring of Neonates

During Phase I, the following steps will be taken:

A trained study nurse will assess the subject for clinical complications before attaching the temperature monitoring device.

A trained study nurse or clinician will attach the temperature monitoring device to the infant. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. They will also be able to answer any technical questions from the nurse.

The trained study nurse will attach the temperature probe from the commercial patient monitor as well as provide any other care needed.

A research assistant will use a laptop to collect the electrical signals from both temperature monitors.

Temperature monitoring will continue for up to 3 days. The research assistant may ask the nurse to remove and reapply the temperature monitor during this period.

Upon removal of the abdominal strap at the end of the study, the subject may be monitored for up to one hour in order to assess the effect of the abdominal strap on the skin of the subject.

Once Phase I is complete, Phase II will begin. During Phase II, the following steps will be taken:

A trained study nurse will assess the subject for clinical complications before beginning treatment.

A trained study nurse or research technician will turn the incubator on to begin pre-warming.

A trained study nurse or clinician will attach the temperature probe from the IncuBaby device to the infant and then place the infant in the incubator. A trained research assistant from Rice University or from the Biomedical Engineering Department at Malawi Polytechnic will observe all procedures and will notify the nurse of any observed errors so they may be corrected. They will also be able to answer any technical questions from the nurse.

The trained study nurse will attach the temperature probe from the commercial patient monitor as well as provide any other care needed.

A research assistant will use a laptop to collect the data from both devices.

Care will be continued at the discretion of the clinician until the infant can be weaned from the IncuBaby device. The infant may be weaned to the standard of care or end thermal treatment. The infant will be transitioned to KMC as soon as possible after these eligibility criteria are fulfilled:

Completed other treatment (CPAP, phototherpay, IV) Mom/caregiver becomes available Weight increases > 1000 g Becomes clinically stable Body temperture is stable and not dipping below normal despite thermal support

Based on the discretion of the clinician, the subject may be weaned to KMC or an open cot. The IncuBaby device has a "weaning" setting that turns off the heaters in the incubator but continues to monitor the infant's temperature. If the infant is found to be hypothermic after ending treatment and the clinician recommends continued incubator care, the subject may recommence use of the IncuBaby for treatment.

The commercial patient monitor will alert nursing staff if the baby's temperature becomes too high or too low. Temperature settings for alarms will be set by a clinician so that the high temperature alarm is > 37.5 C, and the low temperature alarm is < 36.5 C. During Phase II, the following steps will be recommended if the commercial patient monitor sounds a high or low temperature alarm. These guidelines were written in accordance with current clinical practice at QECH. The study nurse can also choose to discontinue the use of the IncuBaby device at any time.

High temperature alarm - indicates possible hyperthermia Check that the incubator temperature is at 36C or less. Open the incubator and recheck the baby's temperature If baby's temperature is still above normal remove blankets/clothing If baby is febrile despite these measures look for a clinical reason for the temperature Remove the infant from the IncuBaby device Low temperature alarm - indicates possible hypothermia

Check that the incubator is in on and functioning Check that the temperature probe has not fallen off. Recheck the baby's temperature If temperature still low add blankets/clothing and hat If the temperature is still low look for a clinical reason for the hypothermia

During both phases, a research assistant will be available during the trial to mitigate any complications with the device. A nurse will be available to respond to alarms from the continuous patient monitor. If the subject's guardian, the nurse, or the research assistant indicates concern during the tests, the study treatment can be discontinued and the subject will return to the standard of care.

Intended Data Collection:

Clinical data will be collected on paper forms as is consistent with current clinical practice. Data will be saved on a secure study server for analysis. Clinical and/or research personnel will record information, excluding personal identifiers, on a standardized patient monitoring form. After the subject's participation is complete, a research assistant will collect and scan the form. We will collect the following information:

1. Baseline demographic and relevant medical information
2. Recorded one at enrollment i. Date of study ii. Date of birth iii. Sex iv. Birth weight v. Type of delivery vi. Gestational age at birth vii. Corrected gestational age viii. Abdominal circumference ix. Admission temperature b. Recorded throughout study as clinically collected i. Other comorbidities ii. Medications/treatments given iii. Current weight iv. Temperature measurements taken as standard of care
3. Accuracy a. Recorded automatically by study equipment i. Abdominal temperature from IncuBaby temperature probe and gold standard device ii. Alarms iii. Temperature in incubator* b. CO2 levels c. Humidity levels in the incubator d. Movement/other caregiving e. Fit/tightness of the strap during and/or at end of study f. Ambient temperature g. Routine assessment of abdominal skin (i.e. indentation, skin irritation) h. Strap site assessment during and/or at end of study i. Commercially available patient monitor temperature sensor site assessment during and/or at end of study j. Nurse comments k. Research technicians comments

• Phase II only, if enclosed A log of an observed user error or comments about the device will be used to improve future iterations of the device. The nurse and technician monitoring forms that will be used to record the above variables are attached to this proposal.