Neoneur Feeding System Functionality in the Clinic

Launched by NEONEUR LLC · Aug 30, 2022

Keywords

ClinConnect Summary

The clinical trial titled "Neoneur Feeding System Functionality in the Clinic" is looking at how well a new feeding device, the Neoneur Feeding System, works for newborns who need help with feeding. The trial aims to gather information about the device's performance and how it compares to past data, helping to prepare for a larger study in the future. The study is currently recruiting participants, and it is open to both boys and girls aged from newborns to 70 years old.

To be eligible for this trial, infants must either be preterm babies requiring tube feeding in the Neonatal Intensive Care Unit (NICU) and born before 34 weeks of pregnancy or babies with congenital heart disease (CHD) who need surgery within their first month and were born after 37 weeks. Unfortunately, some infants are not eligible, including those with certain severe health issues or complications. Participants in this study can expect to help researchers understand the Neoneur Feeding System better, which may lead to improved feeding methods for newborns in the future. Your child’s participation could contribute to important advancements in neonatal care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term
• • Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks
• Exclusion Criteria:
• • Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC
• • Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery