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:

  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

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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Page 1 of 1 (2 locations)

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