Factors involved in parental decision-making when providing consent on behalf of extremely preterm infants in the PENUT Trial
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BACKGROUND: Neurodevelopment and growth are primary concerns when neonates are born extremely premature (between 23 and 28 weeks gestation). The focus of the PENUT Trial is to administer erythropoietin (Epo) to extremely preterm infants and to study the potential neuroprotective effects of Epo. The PENUT ethics survey was designed to provide study investigators with parental feedback regarding the consent process for the PENUT Trial and to improve the consent process for future research trials. OBJECTIVES: The objectives of this research thesis are to learn (1) what factors are important to parents who are approached for informed consent to include their infants in a research study and (2) how parents may be influenced by demographic and social factors. The hypothesis is that parents approached prenatally may be more likely to consider enrolling their infants into the PENUT Trial. METHODS: All parents approached to enroll their eligible infants into the PENUT Trial (both consenting and non-consenting parents) were eligible to complete the ethics survey. While completing the survey, parents (1) responded to statements about factors involved in their decision-making process, (2) rated their overall experiences in being asked to join the PENUT Trial, (3) described what ultimately led them to enroll or not to enroll their infants in the PENUT Trial, and (4) responded to demographic questions. RESULTS: Thirty mothers of infants eligible for the PENUT Trial (22 consenting, 8 non-consenting) were approached by a research study coordinator to complete the survey. Of the 22 consenting mothers, 10 were approached prenatally, and 12 were approached postnatally for the PENUT Trial. However, of the 8 non-consenting mothers, only 1 was approached prenatally, whereas 7 were approached postnatally for the PENUT Trial. The ethics survey was completed by 20 of 22 consenting mothers and 6 of 8 non-consenting mothers. The average rating among mothers of their overall experiences with the consenting process for the PENUT Trial was 3.77 (2.75 among non-consenters, 4.00 among consenters) on a scale of 1 (= poor) to 5 (= excellent). Thirteen mothers preferred to be approached for the PENUT Trial by their baby’s neonatologist (6 preferred their OB/GYN, 5 preferred another doctor, 1 preferred a study coordinator, and 10 had no preference). In addition, 14 mothers preferred that the person approaching them was involved in the research trial (5 preferred person not involved, 2 preferred to be approached by those involved and not involved, and 9 had no preference). Lastly, 18 mothers preferred to be approached prenatally (5 postnatally, and 7 had no preference). CONCLUSIONS: Preliminary findings from the PENUT Trial ethics survey support the hypothesis that mothers prefer to be approached prenatally when considering enrollment of their newborn infants into the PENUT Trial. Survey responses also suggest that during the consent process mothers prefer to be approached by either (1) two neonatologists, with one responsible for the baby’s care and the other responsible for the research trial, or (2) one neonatologist who is involved in both the baby’s care and the research trial.