Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health

• Status: Withdrawn
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized clinical trial comparing Omegaven® treatment with standard of care (soybean-based lipid formulation, Intralipid®) on bone health outcomes in infants with esophageal atresia (EA) undergoing surgical repair at Boston Children's Hospital.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

1) Diagnosis of long-gap EA (esophageal gap length >3cm) 2) Age <12 months (not yet reached 12 month birthday) 3) Anticipated surgical repair for management of EA utilizing esophageal traction requiring prolonged intubation, muscle relaxation, and parenteral nutrition dependence.

1. Known genetic bone disease, including osteogenesis imperfecta, idiopathic infantile hypercalcemia, and vitamin D resistant rickets

2. Prior fragility fracture (including humerus or femur)

3. Anticipated hospital stay of less than 4 weeks (28 days)

4. Impaired lipid metabolism

5. Severe hemorrhagic disorder. This is defined as platelets <50 K cells/uL, hemoglobin <7 g/dL, and INR >2.0. Patients treated with full therapeutic anticoagulation (i.e. for treatment of thrombosis) will also be excluded. This does not include patients on anticoagulants at prophylactic doses.

6. Unstable diabetes mellitus

7. Collapse and shock

8. Stroke/embolism

9. Recent cardiac infarction

10. Undefined coma status

11. Allergy to egg or fish

12. Prior treatment with Omegaven

13. Liver disease (defined as elevated serum aminotransferases and/or direct bilirubin at the time of enrollment)

14. Renal disease (defined as serum creatinine level above the normal range for age at the time of enrollment)

15. Acid or base disorders (defined as serum bicarbonate less than 10 or greater than 40)

16. Preterm infants less than 32 weeks gestation or birthweight <1500 grams who have not had a cranial ultrasound that showed no evidence of intraventricular hemorrhage at 36-40 weeks corrected gestational age

17. Prior diagnosis of intraventricular hemorrhage