A clinical trial is a research study in human subjects with the aim of answering specific questions about a new medical treatment.
The initial work programme for the HRB Mother and Baby CTNI involves the implementation of a suite of clinical trials; including PARROT the main Definitive Intervention Study.
The network has developed a number of pilot and feasibility studies including; TEST, MINT and IRELAND. The CTNI has launched a research programme in the area of Clinical Trials Methodology and will launch a nationwide follow up programme for the children who participate in these trials. The initial trial portfolio will also include STRIDER which is funded by a Health Research Board Definitive Intervention award and NIMBUS which is funded by a Health Research Board Health Research Award.
A Definitive Intervention Study is a clinical study in which participants are assigned to receive one or more interventions, like a new treatment, medicine or procedure, or no intervention, so that researchers can evaluate the effects of the interventions. Intervention studies can generally be considered as either preventative (to see whether an agent or procedure reduces the risk of developing a particular disease) or therapeutic (to assess how well an agent or procedure works to tackle symptoms, prevent recurrence, or reduce mortality). A Definitive Intervention study addresses questions of direct relevance to the improvement of patient care, the health of the public and/or health services and should have the strong potential to have immediate use in everyday practice and policy and decision makers.
A Pilot Study is a version of the main study that is run in miniature to test whether the components of the main study can work together. They are focused on the processes of the main study to ensure recruitment, randomization, treatment and follow-up assessments all run smoothly. They resemble the main study in many respects including an assessment of the primary outcome
A Feasibility Study is a piece of research done before a definitive study in order to answer the question “Can this study be done”? They are used to estimate important parameters that are needed to design the main study.
Our main Definitive Intervention studies are:
PARROT is a multi-centre stepped wedge RCT of plasma PIGF (Placenta Growth Factor) measurement in women who present with suspected pre-eclampsia prior to 37 weeks gestation.
The STRIDER study is a randomised double blind, placebo-controlled clinical trial to quantify the effects of administration of sildenafil on pregnancy outcome in severe early-onset intrauterine growth restriction (IUGR).
Our Pilot Studies and Feasibility Work are:
TEST – An Open-Label Randomized-Controlled Trial of Low dose Aspirin with an Early Screening Test For Pre-eclampsia and Growth restriction.
MINT – The use of Milrinone in neonates with persistent pulmonary hypertension of the newborn.
IRELAND – Aspirin for Optimising Pregnancy Outcome in Pre-gestational Diabetes.