Arginine and ADMA levels during recovery from neonatal abdominal surgery
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)
This will test whether blood levels of arginine and ADMA can help predict recovery and complications in babies born after 35 weeks who need abdominal surgery in the first five days of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | N/A to 5 Days |
| Sex | All |
| Sponsor | Liverpool Women's NHS Foundation Trust Academic / other |
| Locations | 2 sites (Liverpool, Merseyside and 1 other locations) |
| Trial ID | NCT06731855 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study across Liverpool Women's Hospital and Alder Hey Children's Hospital that measures arginine and asymmetric dimethylarginine (ADMA) from leftover serum of routine blood tests in neonates having abdominal surgery. No extra blood will be taken and all infants will receive standard clinical care according to local protocols. Samples will be collected preoperatively and serially up to 30 days postoperatively, with biochemical analysis by ELISA to quantify arginine and ADMA. The investigators aim to correlate the arginine:ADMA relationship with recovery patterns and postoperative complications.
Who should consider this trial
Good fit: Ideal candidates are infants born after 35 weeks gestation with congenital abdominal malformations requiring major gastrointestinal surgery within the first five days of life whose parents can give informed consent.
Not a fit: Infants unlikely to survive the immediate postoperative period, those with known or suspected inborn errors of metabolism or severe liver dysfunction, or those without adequate routine residual serum samples are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, measuring arginine and ADMA could help identify babies at higher risk of complications and inform treatments such as arginine supplementation to improve recovery.
How similar studies have performed: Prior studies in adults undergoing abdominal surgery have linked arginine and ADMA levels with recovery, but applying this biomarker approach to neonatal abdominal surgery is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Liverpool, Merseyside and 1 other locations
- Alder Hey Childrens Hospital NSH Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
- Liverpool Womens Hospital NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Colin Morgan
- Email: colin.morgan@lwh.nhs.uk
- Phone: 0151 7024382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.