RecruitingACTRN12622001307796

Study of newborn infants with stomas. To assess complications and death rates after stoma formation as well as the reasons for stoma formation and the timing of stoma closure.

Rates of Morbidity and Mortality Associated with Neonatal Stomas. A prospective observational study to assess morbidity and mortality after neonatal stoma formation, in addition to indications and timing of closure.


Sponsor

Timothy Little

Enrollment

50 participants

Start Date

Aug 30, 2022

Study Type

Observational

Conditions

Summary

Stoma formation in the neonatal period is necessary in many surgical conditions. There remains debate surrounding a number of factors (such as indications, type, timing of closure) and a paucity of quality literature to inform these decisions. The study aims to give an accurate reflection of practice and outcomes in Australia and New Zealand. Results will be used to aid and improve decision-making for this vulnerable group of patients


Eligibility

Sex: Both males and femalesMax Age: 30 Dayss

Plain Language Summary

Simplified for easier understanding

When a newborn baby needs bowel surgery, surgeons sometimes need to create a stoma — an opening on the surface of the abdomen to allow waste to exit the body while the bowel heals. Stomas can be life-saving for very sick newborns, but there are many unanswered questions about when they are best used, which type to create, and when to close them. This study is a carefully designed observational registry across Australia and New Zealand to capture real-world data on all neonatal stomas performed over a minimum 3-month period. It is not a treatment study — no changes are made to care — but the data collected will help clinicians better understand complications, survival rates, and decision-making around stoma formation and closure for this vulnerable group of patients. Eligibility is specific to newborns: any infant receiving a new gastrointestinal stoma (including gastrostomy, small bowel enterostomy, or colostomy) during the study recruitment period may be included. Infants over 30 days corrected gestational age are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Exposure group = infants </=30 days corrected gestational age undergoing surgery and formation of a gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during th

Exposure group = infants </=30 days corrected gestational age undergoing surgery and formation of a gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period). Information collected includes demographics, clinical status, operation performed and any complications. No active involvement of participants: all data collected from medical records. Period of observation is 3-month period September-November 2022, with a 3-month follow-up period December 2022 – February 2023


Locations(9)

Womens and Childrens Hospital - North Adelaide

NSW,QLD,SA,TAS,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,TAS,WA,VIC, Australia

Queensland Children's Hospital - South Brisbane

NSW,QLD,SA,TAS,WA,VIC, Australia

Mater Women's & Children's Private Health Services - South Brisbane

NSW,QLD,SA,TAS,WA,VIC, Australia

Monash Children’s Hospital - Clayton

NSW,QLD,SA,TAS,WA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,SA,TAS,WA,VIC, Australia

Townsville University Hospital - Douglas

NSW,QLD,SA,TAS,WA,VIC, Australia

Perth Children's Hospital - Nedlands

NSW,QLD,SA,TAS,WA,VIC, Australia

Auckland, Waikato, Wellington & Christchurch, New Zealand

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ACTRN12622001307796