GastroschisisSuNDiALNCT06731855
An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels
An observational study of Gastroschisis and Congenital Diaphragmatic Hernia, run by Liverpool Women's NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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 to congenital abdominal malformations as the participants recover from surgery. Read more about this study
- Who is it for?
- Ages Up to 5 days
- Conditions the study is for
- Gastroschisis, Congenital Diaphragmatic Hernia, Duodenal Atresia
- What is being tested?
- Abdominal Surgery for congenital gut malformation in the first 5 days of life.
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Feb 2024to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population with be of 30 infants born >35 weeks gestation and has a condition requiring major gastrointestinal surgery within 5 days (120 hours) of birth. This is expected to include predominantly congenital gut malformations: gastroschisis, gut atresias, volvulus and congenital diaphragmatic hernia (who are stable enough for surgery in this time frame). Patient will be recruited over a 1 year period. These infants will be born at Liverpool Women's Hospital or at their local hospital in the north west of England region, and transferred to Alder Hey Children's Hospital for their operation, either directly or via Liverpool Women's Hospital Neonatal Intensive Care Unit. They will recover in Alder Hey Children's Hospital's Paediatric Intensive Care Unit or Neonatal Surgical Unit and may later be transferred back to Liverpool Women's Hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Alder Hey Childrens Hospital NSH Foundation Trust
Liverpool, Merseyside, L12 2AP
Colin Morgan, BMedSci BM BS MRCP FRCPCH MD, +447842153126, colin.morgan@lwh.nhs.uk
Joshua Stead, MBChB MPhil MRCPCH, +447532068608, joshua.stead@nhs.net
- Recruiting
Liverpool Womens Hospital NHS Foundation Trust
Liverpool, Merseyside, L8 7SS
Colin Morgan, BMedSci BM MRCP FRCPCH MD, +447842153126, colin.morgan@lwh.nhs.uk
Joshua Stead, MBChB MPhil MRCPCH, +447532068608, joshua.stead@nhs.net
About this study
Official title: An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)
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.
Read more
Neonates born after 35 weeks gestation who have a congenital abdominal malformation who require abdominal surgery in the first 5 days will be eligible to participate in the SuNDiAL study.
Arginine and ADMA will be measured from blood samples that are left over from the participant's blood tests that are taken as part of their routine clinical care. The investigators will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until the participant fully recovers from surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken.
Serums samples that are left over from the babies routine clinical blood tests will be stored securely in the hospitals laboratory until analysis for Arginine and ADMA.
The levels of Arginine and ADMA will be compared to the time it takes the participants to recover from surgery and any complications that may arise following surgery. During the study the study team will use the participants electronic medical record to establish when the participant became fully established on oral feeding and monitor for any complications that occurred during their recovery.
Read the 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 Children's Hospital Foundation Trust.
There is no study intervention and therefore all participants will be managed in accordance with existing local protocols and current accepted clinical practice. Participants will receive standard neonatal and surgical care as per the local clinical guidelines. The participant will have routine blood tests taken as part of their routine care. No additional blood or blood tests will be taken for the SuNDiAL study.
The study will involve the analysis of any blood left over from samples taken routinely pre and postoperatively in infants who have undergone abdominal surgery. Residual serum samples will be analysed from the blood samples taken for routine blood monitoring in the infants enrolled in the study. Biochemical samples will undergo Enzyme-linked immunosorbent assay (ELISA) analysis for ADMA and arginine.
The study period is from preoperatively until 30 days post operatively or until the baby fully recovers from surgery, marked by being fully fed with milk into their stomach. The aim is to obtain at least 1 measurement preoperatively, and a minimum of 4 measurements in the post-operative period. The expectation is that 3-5 measurements first 10 postoperative days should be achievable.
The SuNDiAL study will aim to determine if the level of ADMA and/or Arginine and/or the Arginine to ADMA ratio is associated with the time taken to recover following major abdominal surgery in neonates born after 35 weeks gestation. Recovery will be measured as the time taken to no longer require intravenous nutrition following surgery as the primary objective.
The secondary objectives include:
- To develop a mathematical model of postoperative ADMA and/or ARG/ADMA ratio. This will allow future randomised controlled trial designs investigating postoperative recovery time to include ADMA and ARG/ADMA in the study protocol. This modelling has the potential to develop future arginine supplementation protocols to target and/or refine arginine dosage and duration based on the trajectory of the ADMA levels or arginine:ADMA ratio. This approach includes specific post operative complications following surgery that may delay recovery (such as mortality, wound healing, sepsis, parenteral nutrition cholestasis)
- To compare ADMA and/or ARG/ADMA ratio in specific gastrointestinal conditions that require major abdominal surgery.
- To assess ADMA and the ARG/ADMA ratio in specific gastrointestinal conditions that require major abdominal surgery, pre and postoperatively.
- To identify whether amino acid (protein) and/or arginine intake affect plasma ADMA levels in the post-operative period and to incorporate this outcome in future randomised controlled trials investigation arginine supplementation and other nutritional interventions.
Parents of potential participants will be approached preoperatively or up to 5 days postoperatively to complete the informed consent process.
Once the parents of potential participants have had sufficient time to read and process the information regarding the study (minimum 2 hours), and sufficient time to ask questions regarding the study, written consent will be obtained.
Blood samples will be taken by the clinical team routinely as part of their clinical care. Patients will be managed as per accepted clinical practice and local clinical guidelines by the clinical team. There will be no changes from routine practice due to the SuNDiAL study. No extra blood tests will be taken for the SuNDiAL study.
If an infant is eligible and the parents have given consent to participate in the SuNDiAL study, at the time of ordering routine clinical blood tests the clinical team will order an additional dummy blood test 'SUNDIAL store sample'.
If there is any remaining serum following routine clinical blood tests, the 'SUNDIAL store sample' will alert the lab to store the blood sample for the SuNDiAL study. The sample will frozen and be stored in the SuNDiAL area of the research laboratory freezer in Alder Hey Children's Hospital. All samples with serum remaining will be stored. Samples will stop being stored once the patient is fully recovered or after 30 days post operatively which ever occurs first. The sample will be available for the clinical team to do further tests if these are required and this will take priority over testing the blood for research purposes.
Once there is sufficient samples to run an analysis the samples with be transported to the research laboratory. The samples will then be analysed by the ELISA technique, to measure Arginine and ADMA. Samples will be anonymised by the research team prior to being transported to the Research Laboratory in the Institute in the park at Alder Hey Children hospital.
The data will be anonymised prior to analysis. Data will be analysed for both the primary and secondary outcomes outlined above by the University of Liverpool Computational Biological Facility.
- Conditions
- Gastroschisis, Congenital Diaphragmatic Hernia, Duodenal Atresia, Oesophageal Atresia With Tracheo-Oesophageal Fistula, Oesophageal Atresia, Exomphalos
- Being tested
- Abdominal Surgery for congenital gut malformation in the first 5 days of life.
- Keywords
- Neonatal, Abdominal Surgery, Asymmetric Dimethylarginine, ADMA, Arginine, Recovery, Neonate
- Medical subject headings
- Gastroschisis, Hernias, Diaphragmatic, Congenital, Familial duodenal atresia, Esophageal atresia with or without tracheoesophageal fistula, Esophageal Atresia, Hernia, Umbilical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Surgery for congenital gut malformation in the first 5 days of life.Procedure or surgery
Abdominal Surgery for congenital gut malformation in the first 5 days of life. Procedure will depend on the congenital gut malformation.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Infants born >35 weeks gestation and have a condition requiring major gastrointestinal surgery within 5 days (120 hours) of birth. This is expected to include predominantly congenital gut malformations such as gastroschisis, gut atresias, volvulus and congenital diaphragmatic hernia (who are stable enough for surgery in this time frame). Receives: Procedure: Abdominal Surgery for congenital gut malformation in the first 5 days of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal surgery.
The primary outcome measure will investigate the level of plasma ADMA, arginine and ARG/ADMA ratio preoperatively and in the immediate postoperative period (5 days) in infants stratified according to typical (<21 days) or prolonged (>21 days) postoperative PN dependency. The following measures will be compared between the typical and prolonged recover groups:
- The pre-operative level (peak/trough as appropriate) of Arginine, ADMA and the ARG/ADMA ratio.
- The post-operative level (peak/trough as appropriate) within 5 days of surgery of arginine, ADMA and the ARG/ADMA ratio and its relationship to postoperative PN days.
- The maximum per-infant difference between pre-operative and post-operative levels as defined in a) and b).
Measured: From Enrolment to 30 days following surgery
Secondary outcomes (6)
Develop a mathematical model to describe the entire postoperative (30 days) trajectory of Arginine, ADMA and the ARG/ADMA ratio in relation to PN dependency.
Measured: From enrolment until day 30 post operatively.
To study the relationship over time between nutritional intake and arginine, ADMA and the ARG/ADMA ratio.
Measured: From enrolment until day 30 postoperatively.
The relationship over time between clinically monitored postoperative inflammatory and biochemical markers and arginine, ADMA and the ARG/ADMA ratio
Measured: From Enrolment to 30 days post operatively
Impact of individual episodes (including duration) of any recognised postoperative complication (eg wound complications, bowel complications, sepsis) on the recovery time and the mathematical model described above.
Measured: From enrolment to 30 days post operation
Weight Gain/head growth over the study period in relationship to Arginine, ADMA and Arginine to ADMA ratio.
Measured: Enrolment to 30 days post operation.
Level of care and major treatments (eg ventilation, inotropic support, antibiotics for sepsis) during the study period in relation to Arginine, ADMA and the Arginine to ADMA ratio.
Measured: From enrolment to 30 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start5 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Women's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731855
- Sponsor's protocol ID
- 349681
- Acronym
- SuNDiAL
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Physiological Study of Post-operative Recovery in Surgical Neonates and Dimethylarginine:Arginine Levels (SuNDiAL)
- ClinicalTrials.gov ID
- NCT06731855
- Acronym / sponsor ID
- SuNDiAL / 349681
- Conditions
- Gastroschisis, Congenital Diaphragmatic Hernia, Duodenal Atresia, Oesophageal Atresia With Tracheo-Oesophageal Fistula, Oesophageal Atresia, Exomphalos
- Keywords
- Neonatal, Abdominal Surgery, Asymmetric Dimethylarginine, ADMA, Arginine, Recovery, Neonate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liverpool Women's NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Alder Hey Children's NHS Foundation Trust
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 will be eligible to participate in the SuNDiAL study.
Arginine and ADMA will be measured from blood samples that are left over from the participant's blood tests that are taken as part of their routine clinical care. The investigators will measure Arginine and ADMA preoperatively and at least 10 points in the 30 days following their surgery, or until the participant fully recovers from surgery (which ever comes first). There is no intervention in the SuNDiAL study, and there will be no extra blood or blood samples taken.
Serums samples that are left over from the babies routine clinical blood tests will be stored securely in the hospitals laboratory until analysis for Arginine and ADMA.
The levels of Arginine and ADMA will be compared to the time it takes the participants to recover from surgery and any complications that may arise following surgery. During the study the study team will use the participants electronic medical record to establish when the participant became fully established on oral feeding and monitor for any complications that occurred during their recovery.
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 Children's Hospital Foundation Trust.
There is no study intervention and therefore all participants will be managed in accordance with existing local protocols and current accepted clinical practice. Participants will receive standard neonatal and surgical care as per the local clinical guidelines. The participant will have routine blood tests taken as part of their routine care. No additional blood or blood tests will be taken for the SuNDiAL study.
The study will involve the analysis of any blood left over from samples taken routinely pre and postoperatively in infants who have undergone abdominal surgery. Residual serum samples will be analysed from the blood samples taken for routine blood monitoring in the infants enrolled in the study. Biochemical samples will undergo Enzyme-linked immunosorbent assay (ELISA) analysis for ADMA and arginine.
The study period is from preoperatively until 30 days post operatively or until the baby fully recovers from surgery, marked by being fully fed with milk into their stomach. The aim is to obtain at least 1 measurement preoperatively, and a minimum of 4 measurements in the post-operative period. The expectation is that 3-5 measurements first 10 postoperative days should be achievable.
The SuNDiAL study will aim to determine if the level of ADMA and/or Arginine and/or the Arginine to ADMA ratio is associated with the time taken to recover following major abdominal surgery in neonates born after 35 weeks gestation. Recovery will be measured as the time taken to no longer require intravenous nutrition following surgery as the primary objective.
The secondary objectives include:
- To develop a mathematical model of postoperative ADMA and/or ARG/ADMA ratio. This will allow future randomised controlled trial designs investigating postoperative recovery time to include ADMA and ARG/ADMA in the study protocol. This modelling has the potential to develop future arginine supplementation protocols to target and/or refine arginine dosage and duration based on the trajectory of the ADMA levels or arginine:ADMA ratio. This approach includes specific post operative complications following surgery that may delay recovery (such as mortality, wound healing, sepsis, parenteral nutrition cholestasis)
- To compare ADMA and/or ARG/ADMA ratio in specific gastrointestinal conditions that require major abdominal surgery.
- To assess ADMA and the ARG/ADMA ratio in specific gastrointestinal conditions that require major abdominal surgery, pre and postoperatively.
- To identify whether amino acid (protein) and/or arginine intake affect plasma ADMA levels in the post-operative period and to incorporate this outcome in future randomised controlled trials investigation arginine supplementation and other nutritional interventions.
Parents of potential participants will be approached preoperatively or up to 5 days postoperatively to complete the informed consent process.
Once the parents of potential participants have had sufficient time to read and process the information regarding the study (minimum 2 hours), and sufficient time to ask questions regarding the study, written consent will be obtained.
Blood samples will be taken by the clinical team routinely as part of their clinical care. Patients will be managed as per accepted clinical practice and local clinical guidelines by the clinical team. There will be no changes from routine practice due to the SuNDiAL study. No extra blood tests will be taken for the SuNDiAL study.
If an infant is eligible and the parents have given consent to participate in the SuNDiAL study, at the time of ordering routine clinical blood tests the clinical team will order an additional dummy blood test 'SUNDIAL store sample'.
If there is any remaining serum following routine clinical blood tests, the 'SUNDIAL store sample' will alert the lab to store the blood sample for the SuNDiAL study. The sample will frozen and be stored in the SuNDiAL area of the research laboratory freezer in Alder Hey Children's Hospital. All samples with serum remaining will be stored. Samples will stop being stored once the patient is fully recovered or after 30 days post operatively which ever occurs first. The sample will be available for the clinical team to do further tests if these are required and this will take priority over testing the blood for research purposes.
Once there is sufficient samples to run an analysis the samples with be transported to the research laboratory. The samples will then be analysed by the ELISA technique, to measure Arginine and ADMA. Samples will be anonymised by the research team prior to being transported to the Research Laboratory in the Institute in the park at Alder Hey Children hospital.
The data will be anonymised prior to analysis. Data will be analysed for both the primary and secondary outcomes outlined above by the University of Liverpool Computational Biological Facility.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Procedure: Abdominal Surgery for congenital gut malformation in the first 5 days of life.Infants born >35 weeks gestation and have a condition requiring major gastrointestinal surgery within 5 days (120 hours) of birth. This is expected to include predominantly congenital gut malformations such as gastroschisis, gut atresias, volvulus and congenital diaphragmatic hernia (who are stable enough for surgery in this time frame). |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population with be of 30 infants born >35 weeks gestation and has a condition requiring major gastrointestinal surgery within 5 days (120 hours) of birth. This is expected to include predominantly congenital gut malformations: gastroschisis, gut atresias, volvulus and congenital diaphragmatic hernia (who are stable enough for surgery in this time frame). Patient will be recruited over a 1 year period. These infants will be born at Liverpool Women's Hospital or at their local hospital in the north west of England region, and transferred to Alder Hey Children's Hospital for their operation, either directly or via Liverpool Women's Hospital Neonatal Intensive Care Unit. They will recover in Alder Hey Children's Hospital's Paediatric Intensive Care Unit or Neonatal Surgical Unit and may later be transferred back to Liverpool Women's Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Surgery for congenital gut malformation in the first 5 days of life.Abdominal Surgery for congenital gut malformation in the first 5 days of life. Procedure will depend on the congenital gut malformation. | Procedure or surgery | Study Population |
Primary outcome
The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal surgery.
Time frame: From Enrolment to 30 days following surgery
The primary outcome measure will investigate the level of plasma ADMA, arginine and ARG/ADMA ratio preoperatively and in the immediate postoperative period (5 days) in infants stratified according to typical (<21 days) or prolonged (>21 days) postoperative PN dependency. The following measures will be compared between the typical and prolonged recover groups: 1. The pre-operative level (peak/trough as appropriate) of Arginine, ADMA and the ARG/ADMA ratio. 2. The post-operative level (peak/trough as appropriate) within 5 days of surgery of arginine, ADMA and the ARG/ADMA ratio and its relationship to postoperative PN days. 3. The maximum per-infant difference between pre-operative and post-operative levels as defined in a) and b).
6 secondary outcomes
Develop a mathematical model to describe the entire postoperative (30 days) trajectory of Arginine, ADMA and the ARG/ADMA ratio in relation to PN dependency.
Time frame: From enrolment until day 30 post operatively.
To study the relationship over time between nutritional intake and arginine, ADMA and the ARG/ADMA ratio.
Time frame: From enrolment until day 30 postoperatively.
The relationship over time between clinically monitored postoperative inflammatory and biochemical markers and arginine, ADMA and the ARG/ADMA ratio
Time frame: From Enrolment to 30 days post operatively
Impact of individual episodes (including duration) of any recognised postoperative complication (eg wound complications, bowel complications, sepsis) on the recovery time and the mathematical model described above.
Time frame: From enrolment to 30 days post operation
Weight Gain/head growth over the study period in relationship to Arginine, ADMA and Arginine to ADMA ratio.
Time frame: Enrolment to 30 days post operation.
Level of care and major treatments (eg ventilation, inotropic support, antibiotics for sepsis) during the study period in relation to Arginine, ADMA and the Arginine to ADMA ratio.
Time frame: From enrolment to 30 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis and Congenital Diaphragmatic Hernia, run by Liverpool Women's NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin Morgan (0151 7024382, colin.morgan@lwh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between Arginine, ADMA and the Arginine to ADMA ratio in comparison to the time taken to recover from abdominal surgery. (time frame: From Enrolment to 30 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.