Table 1.
Selection criteria.
| Inclusion criteria | |
|---|---|
| 1 | Only infants younger than 366 days of age with status post-ileostomy or jejunostomy creation (double-loop enterostomies and split enterostomies (with mucous fistula)) will be included in the study to create a homogenous cohort of patients with similar diseases (e.g., necrotizing enterocolitis [NEC], focal intestinal perforation [FIP]). Also, infants of this age group are unique in several respects, such as the response to parenteral nutrition and its hepatic toxicity, resulting in neonatal cholestasis. The ostomy localization is restricted to the jejunum and ileum. Therefore, the cohort of patients shows a similar bowel length for fluid, vitamin, and electrolyte absorption. |
| 2 | All patients with meconium ileus are included in the study. If later (required) diagnostics verify cystic fibrosis, the diagnostics as well as the diagnosis need to be documented in the eCRF, and subgroups will be established in further analysis. |
| 3 | Signed written informed consent will be obtained from parents/legal guardians indicating their willingness to comply with the treatment and follow-up procedures for their child. |
| Exclusion criteria | |
|---|---|
| 1 | The resection of the ileocecal valve is an exclusion criterion because of its association with extensive bowel resection and therefore prolonged parenteral nutrition [15]. |
| 2 | Colostomy. |
| 3 | Patients with small bowel atresia are excluded because of prenatally underdeveloped bowel distal to the atresia. |
| 4 | Multiple ostomies (more than just an enterostomy and a mucous fistula). |
| 5 | Patients with chromosomal abnormalities (if known at the time of randomization) are excluded because of potential malabsorption and malnutrition due to an underlying syndrome. |
| 6 | Hirschsprung disease secondary exclusion. |
| 7 | Participation in another drug-intervention study. |
| 8 | Intestinal perforation due to congenital heart defects with impairing hemodynamic. |