Abstract 200 Clinical Bioethics Poster Symposium, Tuesday, 5/4

Background: Informed consent is essential to the conduct of clinical trials in the NICU. Due to the design of RCT's, parents might have limited time to make their decision, or only one parent may be available.

Objective: To determine if time between birth and presentation of RCT information, and to whom the information was first presented, influenced the decision of parents to enrol or not to enrol their infant in a RCT of α1-Proteinase Inhibitor Therapy for prevention of bronchopulmonary dysplasia. The study population included infants with a birth weight of 600-1250g. The study protocol involved infusions of a blood product, and multiple blood and tracheal aspirate sampling.

Method: Parents of eligible infants were given a verbal explanation and written information about the trial by the study nurse. The trial protocol required that consent be obtained and study manouever commenced prior to 24 hours of age. The number of hours between birth and presentation of study information, as well as who was approached to make a decision [mother first (MF), mother only (MO), father first (FF), father only (FO), or both parents (B)], was recorded on the eligibility log by the study nurse. Parents were given as long as possible to make their decision. Parents who wished to enrol immediately upon presentation of information were asked to reflect on their decision for at least 1 hour. Parents who decided to decline upon presentation of the information were thanked for their time, and recorded as declined.

Results: No significant difference was observed between those who consented or declined based upon who was approached first for consent (n=158). When examined, ≤12hr or >12hr after delivery of the infant, again no difference was observed between groups (n=155). (Table)

Table 1 No caption available
Full size table

Conclusion: Data suggests that within 24 hours of an infant's birth, timing of presentation of information about an RCT, or approaching parents individually or as a couple does not influence whether they agree to enrol their child in a RCT or not.