Surfactant application in very preterm infants
Conditions
Interventions
Group 1: Very preterm infants (22 0/7 to< 312 60/7 weeks gestational age at birth) who are non-invasively ventilated and require endotracheal surfactant.
In this observational study, there will be onl
Sponsors
LMU Klinikum, Abteilung für Neonatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Very preterm infants (22 0/7 to 31 6/7 weeks gestational age at birth) who are non-invasively ventilated and require endotracheal surfactant
Exclusion criteria
Exclusion criteria: 1) severe congenital malformation, which is adversely affecting initial lung aeration, 2) insufficient ability of the parents to understand the study, 3) infant too unstable for data recording
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in lung aeration, i.e. changes in end-expiratory lung impedance (?EELI) over various interventions. ?EELI will be measured using electrical impedance tomography using a belt which is applied at the nipple level before surfactant administration. EIT data will then be extracted on a breath-by-breath basis for each of the interventions noted below. For each measurement, a timeframe of 15 seconds before and 15 seconds after the respective intervention will be recorded except for the follow-up measurements where at least 15 seconds with artefact-free tidal ventilation will be selected for analysis in a timeframe of +/- 1 minute surrounding the respective timepoint. All EELI values at each of the timepoints below will be measured and subtracted from the baseline value before the first handling of the infant. Interventions/timepoints for analysis -Baseline -Application of first medication for analgosedation -Insertion of laryngoscope -If performed: nasopharyngeal suctioning -Insertion of endotracheal tube or LISA catheter -In case of intubation: connection of ventilator to ETT -Surfactant application -In case of intubation: fixation of endotracheal tube -Follow-up: 1, 3, 5, 15, 30 and 60 minutes after end of surfactant application | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include various physiological and clinical parameters (heart rate, oxygen saturation, fraction of inspired oxygen, etc.), as well as global and regional EIT data at pre-defined timepoints. Also, the effect of concomitant interventions (e.g. pressure level adjustments, duration of interventions, etc) will be recorded. | — |
Countries
Germany
Contacts
Public ContactVincent Gaertner
LMU Klinikum
Outcome results
None listed