Clinical trial

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

Name
109470
Description
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.
Trial arms
Trial start
2018-08-03
Estimated PCD
2020-12-17
Trial end
2020-12-17
Status
Withdrawn
Phase
Early phase I
Treatment
Gastrografin
Gastrografin group
Arms:
Drug: Gastrografin
Other names:
Diatrizoate Meglumine, Diatrizoate Sodium
Primary endpoint
Time to Start Feeds
From the date of admission at the hospital to the date feeding is initiated, assessed up to 6 months
Time to Reach Full Feeds
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
Eligibility criteria
Inclusion Criteria: - Diagnosis of gastroschisis Exclusion Criteria: * Gestational age less than 32 weeks * Birth weight less than 1500 grams * Definitive bowel atresia based on physician diagnosis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-11-01

1 organization

1 product

3 indications

Indication
Gastroschisis