The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.

NCT03334578 | Withdrawn Phase 4

• 1 other identifier: 109470
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the use of a drug called Gastrografin to aid in bowel mobility for paediatric patients who have undergone gastroschisis surgery. Gastroschisis is an abdominal wall birth defect where the bowel protrudes through a small opening beside the umbilicus. In these patients, the bowel is often less mobile due to its exposure outside of the body during fetal development. It is common for the bowel to be swollen and matted, which decreases motility and makes it increasingly difficult for the baby to have normal bowel function. Administering Gastrografin facilitates the entry of water into the intestines and bowel, which is thought to aid in bowel function and motility. This study will compare gastroschisis patients who received Gastrografin to gastroschisis patients collected as part of an ongoing observational study at our centre who did not receive Gastrografin.

Conditions

Gastroschisis; Bowel Obstruction; Birth Defect

Outcome Measures

Primary Outcomes (2)

• Time to Start Feeds

  The length of time in days from admission/birth to initiate feeding.

  From the date of admission at the hospital to the date feeding is initiated, assessed up to 6 months

• Time to Reach Full Feeds

  The length of time in days from when feeding was initiated to when baby is considered fully fed

  From the date feeding was initiated to the date when the patient reaches full feeds (defined clinically- varies based on individual patient), assessed up to 6 months

Secondary Outcomes (3)

• Length of Hospital Stay

  upwards of 6 months based on receiving standard care

• Complication Rate

  Up of 6 months

• Operative rate

  Up to 6 months

Study Arms (2)

Drug: Gastrografin

EXPERIMENTAL

Patient will receive 30ml of Gastrografin (diluted at 1:3 ratio with water) as recommended by the manufacturer for a single dose in our population. The dose will be given via the nasogastric tube, which will then be clamped for 1 hour. Gastrografin will only be given if there is evidence of a bowel obstruction. Additionally, Gastrografin will only be given when the patient is hemodynamically stable, not receiving any inotropes, and off of invasive respiratory support. Once administered the patient will receive an x-ray at 48 hours. If Gastrografin can be viewed past the obstruction than another dose of Gastrografin (30ml at 1:3 dilution ratio with water via NG tube) can be given. If gastrografin is not viewed past the obstruction than another dose will not be given. Generic name: Diatrizoate Meglumine, Diatrizoate Sodium

Drug: Gastrografin

Control: Standard care

NO INTERVENTION

This group will be recruited from an ongoing observational study at our centre. The patients in this group have all received the standard care for treating gastroschisis and any potentially associated bowel obstruction. They have not received Gastrografin. They will be recruited between May 2010 and May 2019.

Interventions

Gastrografin DRUG

Gastrografin group

Also known as: Diatrizoate Meglumine, Diatrizoate Sodium

Drug: Gastrografin

Eligibility Criteria

• Age: 32 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Diagnosis of gastroschisis

You may not qualify if:

• Gestational age less than 32 weeks
• Birth weight less than 1500 grams
• Definitive bowel atresia based on physician diagnosis

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Gastroschisis; Intestinal Obstruction; Congenital Abnormalities

Interventions

Diatrizoate Meglumine; Diatrizoate

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hexosamines; Amino Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: August 3, 2018
• Primary Completion: December 17, 2020
• Study Completion: December 17, 2020
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)