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What do parents think about enrolling their premature babies in several research studies?

¹ Neonatal Services, The Royal Women’s Hospital, Melbourne, Victoria, 3053, Australia
² Faculty of Human Development, Victoria University, Melbourne

Correspondence to:
Correspondence to:
Professor Morley
Neonatal Services, Royal Women’s Hospital, 132 Grattan Street, Carlton, VIC 3053, Australia; colin.morley{at}rwh.org.au

Objective: To investigate parents’ opinions about enrolling their premature baby into several research studies in the few days after birth.

Methodology: A questionnaire was given to parents of premature babies in the neonatal intensive care unit who had been invited to join several studies (two to seven).

Results: All 50 mothers and 42 of 48 fathers completed the questionnaire independently; 28% had been asked to join two studies, 32% three, 24% four, 14% five, and 2% six studies. There were 61 babies with mean (SD) gestational age 26.9 (1.6) weeks and birth weight 877 (249) g. Nearly three quarters (71%) of the parents thought it was very good for their baby to be in a hospital that was carrying out a lot of research. Most (93%) thought that their baby would get the same or better care in a study. Only 15% thought their baby was too small for research studies. Almost all (98%) wanted to be involved in the decision about their baby joining a study. Only 22% were worried about the number of studies; 10% would not enrol their baby in any studies, but 74% were willing for their baby to join two or more studies, and 10% would enrol in all the studies. Most (94%) believed that their baby’s participation would improve care of future babies.

Conclusions: Most of these parents were willing to join several studies. The majority were not worried about their baby participating in the studies. The profession needs to be aware that parents are supportive of neonatal research and participation in multiple studies.

Abbreviations: NICU, neonatal intensive care unit; RCT, randomised controlled trial

Keywords: clinical trials; consent; ethics; parents

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