NCT03127345

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Typical duration for phase_2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

April 7, 2017

Last Update Submit

September 12, 2019

Conditions

Esophageal Atresia

Outcome Measures

Primary Outcomes (1)

  • Change in total volumetric bone mineral density of the distal femur

    Computed tomography

    Baseline and 28 days

Secondary Outcomes (5)

  • Cortical and trabecular volumetric bone mineral density of the distal femur

    Baseline and 28 days

  • Bone geometry and bone strength estimates of the distal femur

    Baseline and 28 days

  • Bone turnover markers

    Baseline, 14 days, and 28 days

  • Incidence of fracture

    28 days

  • Incidence of adverse events

    Daily for 28 days

Study Arms (2)

Omegaven

EXPERIMENTAL

15 infants with esophageal atresia undergoing surgical repair will receive Omegaven 1 g/kg/day IV infused over 8-24 hours for 28 days

Drug: Omegaven

Intralipid

ACTIVE COMPARATOR

15 infants with esophageal atresia undergoing surgical repair will receive the standard of care lipid formulation (Intralipid) as per hospital protocol for 28 days

Drug: Intralipid

Interventions

OmegavenDRUG

Intravenous omega 3 fatty acid administration

Omegaven
IntralipidDRUG

Standard of care

Intralipid

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \) 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.
  • Known genetic bone disease, including osteogenesis imperfecta, idiopathic infantile hypercalcemia, and vitamin D resistant rickets
  • Prior fragility fracture (including humerus or femur)
  • Anticipated hospital stay of less than 4 weeks (28 days)
  • Impaired lipid metabolism
  • 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.
  • Unstable diabetes mellitus
  • Collapse and shock
  • Stroke/embolism
  • Recent cardiac infarction
  • Undefined coma status
  • Allergy to egg or fish
  • Prior treatment with Omegaven
  • Liver disease (defined as elevated serum aminotransferases and/or direct bilirubin at the time of enrollment)
  • Renal disease (defined as serum creatinine level above the normal range for age at the time of enrollment)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24793452BACKGROUND

  • 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.

    PMID: 21775562BACKGROUND

  • 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.

    PMID: 23770843BACKGROUND

MeSH Terms

Conditions

Esophageal Atresia

Interventions

fish oil triglyceridessoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending in Endocrinology, Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 25, 2017

Study Start

September 1, 2019

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 16, 2019

Record last verified: 2019-09