Study design and population
MP
RECRUITMENT
After institutional review board approval from the ethics committee of Saarland, Saarbrücken, Germany (file number 49/21), this prospective randomized single-center pilot study was performed at the tertiary PCICU of the Saarland University Medical Center, Homburg/Saar, Germany. The study was registered with Deutsches Register Klinische Studien (DRKS-ID: DRKS00025430).During a period of 22 months (05/2021–02/2023), all patients aged 0–18 years with CHD, who required congenital heart surgery procedures and where parental consent was given, were included in this study (Fig. Trial designWe generated a 1:1 randomization: group 1 = STANDARD group treated according to the STANDARD protocol and group 2 = control group treated conventionally. One person (MP) was responsible for the safekeeping of the randomization list. In case of a new recruitment, the responsible principal investigators (MP or SM) allotted the patient to one of the groups as mentioned above.