Esophageal Atresia Clinical Trial
Official title:
Omega 3 Fatty Acid Treatment for Pediatric Musculoskeletal Health
Verified date | September 2019 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 12 Months |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Boston Children’s Hospital |
Fallon EM, Nazarian A, Nehra D, Pan AH, O'Loughlin AA, Nose V, Puder M. The effect of docosahexaenoic acid on bone microstructure in young mice and bone fracture in neonates. J Surg Res. 2014 Sep;191(1):148-55. doi: 10.1016/j.jss.2014.04.005. Epub 2014 Apr 12. — View Citation
Le HD, de Meijer VE, Robinson EM, Zurakowski D, Potemkin AK, Arsenault DA, Fallon EM, Malkan A, Bistrian BR, Gura KM, Puder M. Parenteral fish-oil-based lipid emulsion improves fatty acid profiles and lipids in parenteral nutrition-dependent children. Am J Clin Nutr. 2011 Sep;94(3):749-58. doi: 10.3945/ajcn.110.008557. Epub 2011 Jul 20. — View Citation
Nehra D, Fallon EM, Potemkin AK, Voss SD, Mitchell PD, Valim C, Belfort MB, Bellinger DC, Duggan C, Gura KM, Puder M. A comparison of 2 intravenous lipid emulsions: interim analysis of a randomized controlled trial. JPEN J Parenter Enteral Nutr. 2014 Aug;38(6):693-701. doi: 10.1177/0148607113492549. Epub 2013 Jun 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total volumetric bone mineral density of the distal femur | Computed tomography | Baseline and 28 days | |
Secondary | Cortical and trabecular volumetric bone mineral density of the distal femur | Computed tomography | Baseline and 28 days | |
Secondary | Bone geometry and bone strength estimates of the distal femur | Computed tomography | Baseline and 28 days | |
Secondary | Bone turnover markers | Blood and urine testing | Baseline, 14 days, and 28 days | |
Secondary | Incidence of fracture | Incidence of fracture | 28 days | |
Secondary | Incidence of adverse events | Incidence of adverse events | Daily for 28 days |
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