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Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Ventilation as Compared to Automated Oxygen Adjustment Alone in Preterm Infants With Intermittent Hypoxemic Events During Non-invasive Ventilatory Support

37 participantsStarted 2016-06

Plain-language summary

In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.

Who can participate

Age range96 Hours – 34 Weeks

SexALL

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Inclusion criteria

✓. postmenstrual age \<34 wks GA at study time (\<32 wks GA at birth)
✓. on nasal/nasopharyngeal CPAP or nasal IMV / IPPV
✓. at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Masimo SET, Irvine, CA, averaging time 8 sec; delay 10s)
✓. informed consent obtained from the parents or legal guardian

Exclusion criteria

✕. postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
✕. congenital cyanotic heart disease
✕. no decision for full treatment support
✕. Average FiO2 during the last 24h bevor the active study phase \>0.60 (too sick for non-invasive ventilator support)
✕. Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congenital cystic lung diseases...)
✕. Clinical evidence for seizures
✕. Ongoing Sepsis with hemodynamic compromise (defined as a CrP \> 20mg/l or positive blood culture (for sepsis), and requirement of catecholamines (for hemodynamic compromise))
✕. Need of blood-transfusion during study time

What they're measuring

The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%).

Timeframe: 48 hours

Trial details

NCT IDNCT02774408

SponsorUniversity of Ulm

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

View on ClinicalTrials.gov More Apnea, Hypoxia trials