Status:
RECRUITING
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
Lead Sponsor:
Liverpool Women's NHS Foundation Trust
Collaborating Sponsors:
Alder Hey Children's NHS Foundation Trust
Conditions:
Gastroschisis
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
Up to 5 years
Brief Summary
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 t...
Detailed Description
The study is a prospective observational, physiological study running across the two trust that form the Liverpool Neonatal Partnership; Liverpool Women's Hospital NHS Foundation Trust and Alder Hey C...
Eligibility Criteria
Inclusion Criteria:
- Infants born >35 weeks gestation
- Have a condition requiring major gastrointestinal surgery
- Surgery within the first 5 days (120 hours) following birth (including congenital diaphragmatic hernia who are stable enough for surgery in this time frame).
- 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.
- Must be willing and able to provide informed consent in order to take part in the study
Exclusion Criteria:
- Infants who are unlikely to survive because of poor immediate postoperative condition.
- Infants known (or suspected to have) a diagnosis of inborn error of metabolism or serious liver dysfunction.
- Parent(s)/guardian(s) who are unable to give informed consent.
- 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
Key Trial Info
Start Date :
February 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06731855
Start Date
February 5 2024
End Date
February 1 2026
Last Update
September 29 2025
Active Locations (2)
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1
Alder Hey Childrens Hospital NSH Foundation Trust
Liverpool, Merseyside, United Kingdom, L12 2AP
2
Liverpool Womens Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L8 7SS