Actively Recruiting

Age: 0 - 5Days
All Genders
ID06731855

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

Led by Liverpool Women's NHS Foundation Trust · Updated on 2025-09-29

30

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

L

Liverpool Women's NHS Foundation Trust

Lead Sponsor

A

Alder Hey Children's NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the levels of two naturally occurring amino acids, Arginine and Asymmetric Dimethylarginine (ADMA), in newborns undergoing abdominal surgery within the first five days of life due to congenital abdominal malformations. The study aims to understand how the relationship between these amino acids may predict recovery and complications after surgery, based on previous findings in adult patients. This observational, physiological study is conducted across two hospitals within the Liverpool Neonatal Partnership.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 5Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants born after 35 weeks gestation
  • Infants with a condition requiring major gastrointestinal surgery
  • Surgery must occur within the first 5 days (120 hours) after birth
  • Parent(s)/guardian(s) must understand written and spoken English sufficiently to provide informed consent
  • Parent(s)/guardian(s) must be willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Infants unlikely to survive due to poor immediate postoperative condition
  • Infants with a known or suspected inborn error of metabolism or serious liver dysfunction
  • Parent(s)/guardian(s) unable to provide informed consent
  • Infants from whom the minimum required residual serum samples cannot be obtained from routine blood testing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 5 days after surgery or preoperatively

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility assessment

Surgery

Duration - Occurs within the first 5 days after birth

Participants undergo major abdominal surgery for congenital gut malformations within the first 5 days of life.

Surgery as per routine clinical care

Post-operative Follow-up

Duration - Up to 30 days postoperatively or until full recovery (whichever occurs first)

Participants are monitored with routine blood tests and clinical care to assess recovery from surgery.

Routine blood tests with approximately 3 to 5 measurements in the first 10 days post surgery and additional follow-up as per clinical care

Trial Site Locations

Total: 2 locations

1

Alder Hey Childrens Hospital NSH Foundation Trust

Liverpool, Merseyside, United Kingdom, L12 2AP

Actively Recruiting

2

Liverpool Womens Hospital NHS Foundation Trust

Liverpool, Merseyside, United Kingdom, L8 7SS

Actively Recruiting

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Research Team

C

Colin Morgan

J

Joshua Stead

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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