Omegaven Protocol:Intermediate Size Patient Population
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|ClinicalTrials.gov Identifier: NCT03561194|
Expanded Access Status : Available
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment|
|Parenteral Nutrition Associated Liver Disease||Other: Omegaven|
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||Omegaven Protocol:Intermediate Size Patient Population|
- Other: Omegaven
After the diagnosis of PNALD is made, patients who are followed by the Neonatal Intensive Care Unit, NICU, will contact Dr. Honrubia and Dr. Swarup. Cases may also include referrals of patients with PNALD from other healthcare facilities or self-referrals. If the patient's parents or guardians agree to participate in the study, informed consent will be obtained. The history of present illness and past medical history will be reviewed with the guardian and pertinent demographic and medical information will be recorded on data collection forms. This form will be used to record all laboratory results, nutritional history, and descriptions of any liver biopsies performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561194
|Contact: Margaret Leal, MSemail@example.com|