Informed consent, randomization, and blinding in neonatal resuscitation and immediate care trials

To analyze how the informed consent process, blinding and randomization were conducted in neonatal resuscitation trials.

PubMed, Scopus and Web of Science were searched for randomized controlled trials published between 2016 and 2025 and focusing on neonatal resuscitation and acute care during the first six hours of life. Both studies conducted in delivery rooms and neonatal intensive care units were included. Two authors screened the results and extracted the data.

We screened 567 abstracts, and further assessed 174 full texts, of which 143 were included. From included studies, 108 (75.5%) used written informed consent and the consent was prospective in 89 (62.2%) of the studies. Cochrane's risk of bias tool 2 was used: the bias due to randomization was low in 126 (88.1%) studies and high in only 3.5% of studies. During the study period there was a trend towards less bias due to randomization as the linear regression indicated an improvement in the low risk of bias rate. Personnel blinding was performed in 26 (18.2%) studies, assessor blinding in 56 (39.2%), and data analysis blinding in 29 (20.3%) of the included studies.

Written prospective informed consent was the most used consent method in neonatal emergency situations. Bias due to randomization was generally low but blinding was performed in a minority of studies. These findings provide suggestion to improve the quality of future neonatal resuscitation trials.