Very preterm infants are at increased risk of adverse outcomes in early childhood. We assessed whether delayed clamping of the umbilical cord reduces mortality or major disability at 2 years in the APTS Childhood Follow Up Study.
Despite evidence suggesting that parent involvement was beneficial for infant and parent outcomes, the Family Integrated Care (FICare) programme was one of the first pragmatic approaches to enable parents to become primary caregivers in the neonatal intensive care unit (NICU). We aimed to analyse the effect of FICare on infant and parent outcomes, safety, and resource use.
Engagement underlies research success. Whether it is engagement with existing or new collaborators, the media, governing and funding bodies, or government, and last but not least consumers (formerly called patients), effective communication and dissemination of research findings is essential. The days of pure, unadulterated science, without the need to justify a disease cure are over. With scientific literature written in a style that is virtually impossible for the layperson to read and interpret, social media provides an alternative broadcasting strategy…
Doctors should never be obliged to invite patients to join trials. Instead, we need a self‐improving health system that embeds randomised trials in routine care. ‘We must change community culture so that one of the first questions asked by pregnant women and their families is, “Are there any randomised trials we can join?”’ Melinda Cruz
Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia
BMC Pediatrics201515:210 DOI: 10.1186/s12887-015-0527-0
Admission to the neonatal intensive care unit (NICU) may disrupt parent-infant interaction with adverse consequences for infants and their families. Several family-centered care programs promote parent-infant interaction in the NICU; however, all of these retain the premise that health-care professionals should provide most of the infant's care. Parents play a mainly supportive role in the NICU and continue to feel anxious and unprepared to care for their infant after discharge.
Design and conduct of a large neonatal or obstetric randomized controlled trial
Seminars in Fetal & Neonatal Medicine xxx (2015) 1-14
As event rates fall, if mortality and disability are to improve further there is increasing need for large, well-designed trials. These should enrol more patients, more rapidly and at lower cost, with better representation of infants at highest risk and greater integration with routine care.
Dealing with the Unknown: Reducing the Proportion of Unvalidated Treatments Offered to Children
Arch Dis Child Fetal Neonatal Ed February 18, 2015
When, on the basis of up-to-date, well-conducted systematic reviews of relevant evidence, we know we do not know and yet we fail to act, people have suffered and died unnecessarily. For example, the consequence of decade-long delays in addressing uncertainties about the long-term effects of fetal exposure to antibiotics given to women in preterm labour is that many individuals are living today with cerebral palsy that could have been avoided.
The "Research Misconception" and the SUPPORT Trial: Toward Evidence-Based Consensus
The American Journal of Bioethics Volume 13, Issue 12, 2013
Online article or https://www.melindacruz.com/articles-1/2018/6/5/the-research-misconception-and-the-support-trial-toward-evidence-based-consens
Critics of SUPPORT, including Macklin and Shepherd in this issue (2013), argue that its consent forms encouraged the “therapeutic misconception.” They allege that SUPPORT investigators blurred the distinction between research and clinical care by referring to different treatment options as “standard of care.” They contend that information statements ignored or downplayed the risks of participating in the research.
Strategies to accelerate recruitment to NHMRC multi-centre clinical trials
Journal of Paediatrics and Child Health. Volume 49, Issue 1, pages E103–E105, January 2013
All these trials are likely to have significant impact on clinical practice because they were reported in the world's most highly cited medical journal. They illustrate the need to invest considerable resources and time, often well beyond 5 years, to address important study questions, rather than curtailing recruitment, diminishing power and scientific validity.
Evaluating Therapeutic Hypothermia Parental Perspectives Should Be Explicitly Represented in Future Research
Archives of Paediatrics and Adolescent Medicine VOL 166 (NO. 6), June 2012
The systematic review of randomized controlled trials by Tagin et al in this issue of the Archives1 confirms therapeutic hypothermia, or cooling, as a major advance for infants with hypoxic ischemic encephalopathy (HIE). The evidence, achieved during 2 decades of international collaboration, reflects great credit on the neonatal community, parents, researchers, funding agencies, and providers of health care.
Evidence-based neonatal medicine in Latin America; what can we learn from the International Neonatal Study and trials of IVIg?
Jornal de Pediatria Copyright © by Sociedade Brasileira de Pediatria
Although reliable randomised trials are essential to guide policy and avoid unnecessary expenditure on ineffective treatments, very few babies or pregnant women in Latin America, and in the rest of the world, are recruited into multicenter perinatal trials.
In 2012, Melinda Cruz was awarded the title of Honorary Research Associate by the University of Sydney, Medical School and was the first parent to be invited as an Associate Investigator (2012) and a Chief Investigator (2019) on National Health and Medical Research Council (NHMRC) funded neonatal trials.
In 2014, Melinda joined the Perinatal Society of Australia & New Zealand's (PSANZ) Consumer Advisory Panel as the inaugural Chair and accepted a position on the PSANZ Clinical Trials executive committee.
In 2015, she joined the Australian Red Cross Blood Service (now known as LifeBlood) Milk Bank Advisory Committee helping to establish the first national Human Breastmilk Bank. In 2016, she was asked to join the NHMRC Clinical Trials Ready Development Committee and in 2017 and 2018, was part of two award-winning global trials improving the lives of millions of premature newborns. In 2019, she was the inaugural winner of the Australian Clinical Trials Alliance (ACTA) Consumer Involvement Award.
To date, Melinda has co-authored 10 medical publications and is a contributor to THRIVE Global – an international hub for information on wellness.