Project Lead(s): Anibal Anticona Vera
Around 10% of all live births worldwide are preterm (defined as birth prior to 37 weeks gestational age).
Compared to full-term infants, premature infants have higher incidence of long-term neurodevelopmental and cognitive impairments, including cerebral palsy, motor deficits, cognitive impairments, and social and emotional difficulties.
These impairments have been increasingly associated with stress in the neonatal intensive care unit (NICU) and research suggests that auditory-tactile stimulation can play a key role in reducing stress for the infant while in the NICU.
The team sought to test the efficacy of pulsatile auditory-tactile stimulation (PATS) to reduce stress and pain, as well as to promote weight gain of premature infants who are hospitalized in the NICU.
PATS is a low-cost mattress used as the premature infant lies in the incubator. On the side in contact with the newborn, the mattress has a plastic pocket containing a water film. Through this water film, an electronic device emits a system of continuous sounds, similar to the heartbeat.
The result is a pulsatile tactile-auditory stimulus that is similar to a soft massage. The stimulus duration is 25 hundredths of a second and the frequency is 60 per minute (like the normal heart rate of an adult at rest).
Due to the suspension of all authorization for clinical studies in children in Peru, the project team was unable to conduct a clinical study. However, the safety of the approach with preterm infants was confirmed in a pilot study in 2006.
The team developed a prototype device that potentially could be used to relieve infant stress in neonatal intensive care units and performed laboratory tests (electrical and sound tests) of the prototype to verify that it met technical standards.
The team has developed a product, called Baby Sweet Dreams, which is meant to be used as a baby’s bassinet and would include the PATS technology.
The team intends to apply for Transition To Scale Phase II funding ,in order to validate the PATS prototype for use in preterm infants in the NICU.
The plan is to conduct a clinical trial on preterm infants at the Hospital Nacional Edgardo Rebagliati Martins (HNERM) Lima, provided they obtain the authorization from the national authority in Peru.
They plan to scale the use of PATS in non-hospitalized infants through the development of the product Baby Sweet Dreams (BSD).
They will apply to national grants for entrepreneurships, including ‘Start Up Peru’ and ‘Capital Semilla’ from the Ministry of Production, to validate the business model and to start with the commercialization of BSD.
A manuscript of the study protocol has been prepared for submission to an open access journal.