Study to examine the effects of different styles of consent documentation on parental understanding and recruitment of babies in neonatal research

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Two consent forms and information sheets, used in: A. United States of America, and B. Edinburgh For the NEOPAIN Multicentre Trial will be tested. The NEOPAIN Trial was an international, randomised, double blind, placebo‐controlled trial of routine morphine infusion versus placebo in ventilated preterm infants. The primary outcomes were published in the Lancet in 2004. Parents will be asked to imagine that their infant was eligible for the study and will be randomised to one of the two forms (A or B), with or without a verbal explanation about the study. After reading the study documentation, they will answer a questionnaire to investigate their understanding, satisfaction and willingness to enrol their infant in the hypothetical study. CONDITION: Neonatal research ; Neonatal Diseases PRIMARY OUTCOME: Parental understanding of the important points of the research study. SECONDARY OUTCOME: 1. Parental satisfaction with information given; 2. Parental willingness to allow their baby to participate in research on the basis of the information given INCLUSION CRITERIA: Parents of infants admitted to the Neonatal Unit within the first 72 hours of life, but not expected to require ventilation.
Epistemonikos ID: eeb9f2246ec92bc1fa392e764962f78819c145c6
First added on: Aug 21, 2024