The NITRIC Follow-up Study

Congenital heart defects (CHDs) are conditions that are present at birth and can affect the structure of a baby’s heart and the way it works. They are the most common type of birth defect with over 1000 infants and children in Australia and New Zealand requiring heart surgery each year. As advancements in medical care and treatment progress, infants with congenital heart defects are living longer and healthier lives. Many now are living into adulthood.

Neurodevelopmental disabilities can be common after surgical repair of congenital heart disease (CHD). Studies have shown that children with CHD can have more problems with learning, behaviour, language and social skills than their peers.

Study Aims

The NITRIC Follow-up Study aims to find out more about the surgery and recovery factors that influence how infants and young children recover and develop their thinking after cardiac surgery.

This will help us determine the best time to provide support for particular outcomes (e.g. physiotherapy, speech therapy).

Information from this study will tell us more about how we should care for children with congenital heart disease after surgery. By understanding these outcomes in children up until school age, we can watch and support children and families better as they enter a new stage in their lives.

Publications

• Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial.

  Published in BMJ Open in 2019; Schlapbach et al.

  This is the publication of the NITRIC randomised controlled trial study protocol, which was published prior to completion of the study. The NITRIC trial studies whether giving nitric oxide during heart surgery can help young children recover faster by increasing ventilator-free days, which is the number of days they spend alive and without needing a ventilator after surgery. The trial will randomly assign 1,320 infants to receive either nitric oxide or standard care (no nitric oxide) during surgery and will measure outcomes like recovery speed, the need for extra support, and hospital length of stay. The study also aims to look at how nitric oxide affects inflammation after surgery.

  Full text available at https://bmjopen.bmj.com/content/9/8/e026664

  
  

• Effect of Nitric Oxide via Cardiopulmonary Bypass on Ventilator-Free Days in Young Children Undergoing Congenital Heart Disease Surgery The NITRIC Randomized Clinical Trial.

  Published in JAMA in 2022; Schlapbach et al.

  This paper discusses the overall results of the NITRIC randomised controlled trial, which tested whether adding nitric oxide to the heart-lung machine during heart surgery could help young children recover faster and have more ventilator-free days. The results showed that there was no significant difference in the number of ventilator-free days, low cardiac output syndrome, or other secondary outcomes between children who received nitric oxide and those who did not. The study concluded that using nitric oxide in this way did not improve recovery or other outcomes for these children.

  Full text available at https://jamanetwork.com/journals/jama/fullarticle/2793781

  
  

• Assessing the impact of risk-based data monitoring on outcomes for a paediatric multicentre randomised controlled trial.

  Published in Clinical Trials in 2024: Journal of the Society for Clinical Trials; Le Marsney et al.

  This article discusses the impact of the risk-based monitoring approach used in the NITRIC randomized controlled trial. During the trial, all important study data was checked carefully against the original record. The researchers found that this amount and type of data monitoring did not significantly change the trial results and was time-consuming (roughly 365 hours of monitoring). The findings suggest that in some contexts, less time-consuming ways of data monitoring could be used without affecting the accuracy of trial results.

  Full text available at https://journals.sagepub.com/doi/10.1177/17407745231222019 '

  
  

• Platelet reactivity in young children undergoing congenital heart disease surgery: a NITRIC randomized clinical trial substudy.

  Published in Intensive Care Medicine – Paediatric and Neonatal in 2024; van Loon et al.

  This is the publication of a smaller, substudy within the NITRIC randomised controlled trial. The NITRIC trial tested if adding nitric oxide to the oxygenator during heart surgery in young children could help them recover better. This smaller study within the trial which looked at platelets (which help with blood clotting) and found that nitric oxide did not change platelet function. Additionally, it found that the length of time a child was on the heart-lung machine also did not affect platelet function.

  Full text available at https://link.springer.com/article/10.1007/s44253-024-00037-2

Please have a look at the video below to learn more about the Nitric Follow-up study