Preterm Birth Clinical Trial
— KangarooOfficial title:
Cerebral Oxygenation in Preterm Neonates With Respiratory Support During Skin-to-skin Care on the First Day After Birth - a Prospective Observational Pilot Study
NCT number | NCT04865302 |
Other study ID # | Kangaroo |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | December 31, 2024 |
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in ventilated preterm neonates on the first day after birth.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Minutes to 24 Hours |
Eligibility | Inclusion Criteria: - Need for respiratory support (endotracheal tube [ETT], nasal continuous positive airway pressure [nCPAP], high-flow nasal cannula [HFNC]) - Decision to conduct full life support - Written informed consent Exclusion Criteria: - No decision to conduct full life support - No written informed consent - Severe congenital malformations, severe asphyxia (umbilical cord artery pH <7.00) - Cerebral malformations, posthaemorrhagic ventricular dilatation, intraventricular haemorrhage grade III, periventricular haemorrhage - Cardiovascular instability (need for catecholamines) - No need for respiratory support |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Pediatrics, Division of Neonatology, Medical University of Graz | Graz | Styria |
Lead Sponsor | Collaborator |
---|---|
Medical University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | leukocyte count | leukocyte count (per µl) - routinely sampled | first 48 hours | |
Other | C-reactive protein | C-reactive protein (mg/l) - routinely sampled | first 48 hours | |
Other | IT-ratio | IT-ratio - routinely sampled | first 48 hours | |
Primary | percent minutes of cerebral hypoxia | After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase I" over 40 minutes. | 60 minutes | |
Primary | percent minutes of cerebral hypoxia | After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "SSC" over 40 minutes. | 60 minutes | |
Primary | percent minutes of cerebral hypoxia | After a 20 minutes washout period the time (percentage of minutes) of cerebral hypoxia (below 54%) will be calculated for intervention period "incubator phase II" over 40 minutes. | 60 minutes | |
Secondary | Mean StO2 | Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase I", after washout time will be calculated | 60 minutes | |
Secondary | Mean StO2 | Mean StO2 values over 40 minutes, calculated for intervention period "SSC", after washout time will be calculated | 60 minutes | |
Secondary | Mean StO2 | Mean StO2 values over 40 minutes, calculated for intervention period "incubator phase II" after washout time will be calculated | 60 minutes | |
Secondary | Mean cFTOE | Mean cFTOE values over 40 minutes for intervention period "incubator phase I" after washout time will be calculated | 60 minutes | |
Secondary | Mean cFTOE | Mean cFTOE values over 40 minutes for intervention period "SSC" after washout time will be calculated | 60 minutes | |
Secondary | Mean cFTOE | Mean cFTOE values over 40 minutes for intervention period "incubator phase II" after washout time will be calculated | 60 minutes | |
Secondary | Mean routine monitoring parameters :SpO2 | SpO2 for intervention period "incubator phase I" | 60 minutes | |
Secondary | Mean routine monitoring parameters :SpO2 | SpO2 for intervention period "SSC" | 60 minutes | |
Secondary | Mean routine monitoring parameters :SpO2 | SpO2 for intervention period "incubator phase II" | 60 minutes | |
Secondary | Mean routine monitoring parameters: HR | HR for intervention period "incubator phase I" | 60 minutes | |
Secondary | Mean routine monitoring parameters: HR | HR for intervention period "SSC" | 60 minutes | |
Secondary | Mean routine monitoring parameters: HR | HR for intervention period "incubator phase II" | 60 minutes | |
Secondary | Mean routine monitoring parameters: RR | RR for intervention period "incubator phase I" | 60 minutes | |
Secondary | Mean routine monitoring parameters: RR | RR for intervention period "SSC" | 60 minutes | |
Secondary | Mean routine monitoring parameters: RR | RR for intervention period "incubator phase II" | 60 minutes | |
Secondary | Mean routine monitoring parameters: MABP | MABP for intervention period "incubator phase I" | 60 minutes | |
Secondary | Mean routine monitoring parameters: MABP | MABP for intervention period "SSC" | 60 minutes | |
Secondary | Mean routine monitoring parameters: MABP | MABP for intervention period "incubator phase II" | 60 minutes | |
Secondary | Mean routine monitoring parameters: temperature | Temperature for intervention period "incubator phase I" | 60 minutes | |
Secondary | Mean routine monitoring parameters: temperature | Temperature for intervention period "SSC" | 60 minutes | |
Secondary | Mean routine monitoring parameters: temperature | Temperature for intervention period "incubator phase II" | 60 minutes |
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