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Lipid Emulsion

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

Phase 4
Waitlist Available
Research Sponsored by Baxter Healthcare Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
No Placebo-Only Group
All Individual Drugs Already Approved
Drug Has Already Been Approved

Summary

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid in a pediatric population.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Essential Fatty Acid Deficiency (EFAD)

Side effects data

From 2022 Phase 4 trial • 101 Patients • NCT04555044
44%
HYPERBILIRUBINAEMIA NEONATAL
30%
PATENT DUCTUS ARTERIOSUS
28%
ANAEMIA NEONATAL
14%
FEEDING INTOLERANCE
12%
INTRAVENTRICULAR HAEMORRHAGE NEONATAL
10%
BLOOD ALKALINE PHOSPHATASE INCREASED
10%
SEPSIS NEONATAL
10%
ATRIAL SEPTAL DEFECT
10%
INFANTILE APNOEA
10%
NEONATAL HYPONATRAEMIA
6%
BRADYCARDIA NEONATAL
6%
URINARY TRACT INFECTION
4%
HYPERCHLORAEMIA
4%
HYPERNATRAEMIA
4%
HYDROCELE
4%
GASTROOESOPHAGEAL REFLUX DISEASE
4%
BLOOD TRIGLYCERIDES INCREASED
4%
OSTEOPENIA
4%
Vomiting
4%
ADRENAL INSUFFICIENCY NEONATAL
4%
HAEMATOCHEZIA
4%
DERMATITIS DIAPER
4%
BRONCHOPULMONARY DYSPLASIA
2%
EYE DISCHARGE
2%
POSTOPERATIVE RESPIRATORY FAILURE
2%
CARDIOVASCULAR EXAMINATION ABNORMAL
2%
GASTRIC FLUID ANALYSIS ABNORMAL
2%
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
2%
NECROTISING ENTEROCOLITIS NEONATAL
2%
URINARY TRACT INFECTION FUNGAL
2%
HYPOTHYROIDISM
2%
ANAL FISSURE
2%
INFUSION SITE EXTRAVASATION
2%
HYPERGLYCAEMIA
2%
DYSPNOEA
2%
ACUTE RESPIRATORY FAILURE
2%
MECONIUM PLUG SYNDROME
2%
VENTRICULAR TACHYCARDIA
2%
NEWBORN PERSISTENT PULMONARY HYPERTENSION
2%
ABDOMINAL DISTENSION
2%
ADMINISTRATION SITE EXTRAVASATION
2%
EYE INFECTION
2%
PHYTOSTEROL LEVEL INCREASED
2%
URINARY TRACT INFECTION NEONATAL
2%
HYDROCEPHALUS
2%
RENAL INJURY
2%
FREE FATTY ACIDS DECREASED
2%
HYPERMAGNESAEMIA
2%
HYPOVOLAEMIA
2%
PNEUMOTHORAX
2%
NEONATAL RESPIRATORY DISTRESS SYNDROME
2%
STRIDOR
2%
RASH ERYTHEMATOUS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clinolipid (Lipid Injectable Emulsion) 20%
Intralipid (SOC Soybean Oil-based Lipid Emulsion)

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Clinolipid (lipid injectable emulsion, USP) 20%Experimental Treatment1 Intervention
Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
Group II: Intralipid 20% (lipid injectable emulsion, USP)Active Control1 Intervention
Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Soybean oil
FDA approved

Find a Location

Who is running the clinical trial?

Baxter Healthcare CorporationLead Sponsor
322 Previous Clinical Trials
202,640 Total Patients Enrolled
6 Trials studying Malnutrition
2,348 Patients Enrolled for Malnutrition
~0 spots leftby Dec 2025
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