Timing of Stoma Closure in Neonates

NCT04713579 | Completed

• 2 other identifiers: B00984G69250
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or "close" the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be better; however surgery is safer when babies are older and bigger so later closure may be better. This study aims to answer the question, 'is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention ('early vs. late') and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes). The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies to help decide whether a clinical trial is possible.

Conditions

Enterocolitis, Necrotizing; Atresia; Bowel; Gastroschisis; Meconium Ileus; Premature Birth; Bowel Obstruction; Perforation Bowel

Keywords

Stoma closure; Infant; Neonatal

Outcome Measures

Primary Outcomes (1)

• Feasibility of a future trial comparing early and late stoma closure

  The key research question 'Is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' will be answered by completing the series of secondary outcome measures using qualitative mixed research methods

  through study completion, an average of 1 year

Secondary Outcomes (7)

• To establish current UK practice for stoma closure in neonates

  through study completion, an average of 1 year

• To determine whether there is equipoise amongst clinicians (neonatal surgeons, and neonatologists) and allied health professionals (specialist nurses and dieticians) over when it is best to close stomas in neonates

  through study completion, an average of 1 year

• To determine the willingness of parents, neonatal surgeons and neonatologists to include neonates in a trial that would randomise to 'early' or 'late' stoma closure and identify potential barriers to recruitment.

  through study completion, an average of 1 year

• To define 'early' and 'late' stoma closure for a potential trial.

  through study completion, an average of 1 year

• Identify a group of babies for inclusion in a trial and find out how many of these babies could be included in the UK.

  through study completion, an average of 1 year

Study Arms (2)

Premature infants

Infants born prematurely requiring a stoma for condition such as necrotizing enterocolitis (NEC) or spontaneous intestinal perforation (SIP).

Other: No intervention - observational study

Term Infants

Infants born closer to term requiring a stoma e.g. for congenital causes of bowel obstruction such as intestinal atresia, gastroschisis or meconium ileus

Other: No intervention - observational study

Interventions

No intervention - observational study OTHER

There is no intervention in this study as it is purely observational.

Premature infants; Term Infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Workstream 1: clinicians involved in caring for infants with stomas in UK surgical units. Workstream 2.1: Infants who have had a stoma formed as part of emergency surgery before 44 weeks post-conceptual age. Workstream 2.2: clinicians involved in caring for infants recruited to WS 2.1. Workstream 2.3: Parents of premature and term infants who have had an stoma in the last three years; clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.

You may qualify if:

• Neonatologists in surgical NICUs, neonatal surgeons, neonatal dieticians and neonatal surgical nurses.
• Workstream 2.1
• Infants having a stoma as part of emergency surgery before 44 weeks post-conceptual age: Group A preterm infants who have stomas formed for necrotising enterocolitis, spontaneous intestinal perforation or other intestinal pathology, and Group B infants (usually born closer to term) who have congenital anomalies that lead to bowel obstruction (e.g. intestinal atresias; meconium ileus and other conditions such as complicated gastroschisis).

You may not qualify if:

• Cases where a stoma is part of a planned treatment pathway e.g. for an anorectal malformation or Hirschsprung's disease.
• Infants who have a stoma formed after 44 weeks post-conceptual age.
• Workstream 2.2
• Lead surgeons and neonatologists caring for infants recruited to WS 2.1.
• Workstream 2.3
• Parents of premature and term infants who have had an stoma in the last three years (including parents of infants recruited to WS 2.1).
• Clinicians in participating surgical units, who are involved in the treatment of infants requiring emergency stoma closure.
• Parents who do not speak English.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Oxford: collaborator
• University of Liverpool: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Intestinal Atresia; Gastroschisis; Meconium Ileus; Premature Birth; Intestinal Obstruction; Intestinal Perforation

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nick Lansdale, MB FRCS PhD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: January 19, 2021
• Study Start: February 17, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

GB (1)