Apnea Treatment in Premature Infants Using an Automatic Vibro-tactile Stimulator Triggered by the Detection of Apnea-bradycardia.

Launched by RENNES UNIVERSITY HOSPITAL · Aug 27, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the SENSITACT system, which aims to help premature infants who experience a condition known as apnea of prematurity. Apnea is when a baby temporarily stops breathing, often accompanied by a drop in heart rate. The SENSITACT system uses gentle vibrations to stimulate the baby when these episodes occur, with the goal of reducing the number and severity of breathing problems without causing discomfort. This method offers an alternative to current treatments, which may not fully address the issue and can be uncomfortable for the baby.

To participate in this trial, infants must be born prematurely (before 34 weeks of pregnancy), be at least 4 days old, and show signs of significant apnea and bradycardia (low heart rate) within a specific timeframe. Unfortunately, babies with certain conditions, such as major birth defects or serious infections, are not eligible. If enrolled, families can expect to work closely with the medical team to monitor the baby's progress and response to this innovative treatment, which could improve comfort and independence for their little ones.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • written informed consent,
• • Premature infants,
• • born to a term less than 34 weeks of amenorrhea (AS),
• • Age less than 36 weeks post-menstrual age,
• • With a postnatal age greater than 4 days,
• • caffeine treated, for at least 36 hours,
• • Presenting episodes of bradycardia apnea significant (\>10 sec with bradycardia \<100 bpm or SaO2\<80%) with an interval of less than 6 hours between two episodes observed in the 24 hours preceding inclusion.
• Exclusion Criteria:
• • Major congenital neurological abnormalities,
• • Congenital abnormalities of the respiratory tracts,
• • HIV grade 3 or 4,
• • Periventricular leukomalacia,
• • Invasive ventilation and non-invasive ventilation in NAVA mode,
• • Cyanogenic malformative heart disease,
• • Sepsis diagnosed in the 4 days prior to registration (CRP\> 10mg / L),
• • maternal addiction during pregnancy,
• • Father and / or mother legally protected (under judicial protection, guardianship or supervision).