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An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels

Recruitingn/aAges any - 5 DaysAllLiverpool Women's NHS Foundation Trust
NCT06731855 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The SuNDiAL study will measure levels of two naturally occurring amino acids: Arginine and Asymmetric Dimethylarginine (ADMA) in neonates undergoing abdominal surgery in the first 5 days of life due to congenital abdominal malformations as the participants recover from surgery. The investigators hypothesise that the relationship between Arginine and ADMA may be useful in predicting recovery and complications in babies who have had abdominal surgery due to previous research published in adult patients undergoing abdominal surgery. If this relationship is found to be useful there may be options for developing treatments (such as arginine supplementation) in the future to improve recovery and reduce complications in neonates undergoing abdominal surgery. Neonates born after 35 weeks gestation who have a congenital abdominal malformation who require abdominal surgery in the first 5 days wi

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Infants born \>35 weeks gestation 2. Have a condition requiring major gastrointestinal surgery 3. Surgery within the first 5 days (120 hours) following birth (including congenital diaphragmatic hernia who are stable enough for surgery in this time frame). 4. Parent(s)/guardian(s) must have a comprehensive understanding of written and spoken English, sufficient to provide informed using the translation services available to the research team. 5. Must be willing and able to provide informed consent in order to take part in the study Exclusion Criteria: 1. Infants who are unlikely to survive because of poor immediate postoperative condition. 2. Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction. 3. Parent(s)/guardian(s) who are unable to give informed consent. 4. Infants who it is not possible to obtain the minimum required residual serum samples from routine biochemical blood testing as outlined in the study schedule
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What it tests

  • Abdominal Surgery for congenital gut malformation in the first 5 days of life.
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Where

2 sites
Alder Hey Childrens Hospital NSH Foundation Trust
Liverpool, United Kingdom
Liverpool Womens Hospital NHS Foundation Trust
Liverpool, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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