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Lipid Emulsion

Clinolipid for Essential Fatty Acid Deficiency

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
Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
Patients and/or their legal representative accept adherence to protocol requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 120 (30 days after subject's last study treatment if hospital discharge has not occurred)
Awards & highlights

Study Summary

This trial will compare two types of fat emulsions given to hospitalized pediatric patients to see which one is more likely to prevent a deficiency of essential fatty acids, and to see how safe and effective either option is.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 120 (30 days after subject's last study treatment if hospital discharge has not occurred)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 120 (30 days after subject's last study treatment if hospital discharge has not occurred) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants to Develop Essential Fatty Acid Deficiency (EFAD) Defined by Holman Index > 0.4
Secondary outcome measures
Alanine Aminotransferase (ALT)
Alkaline Phosphatase
Aspartate Transaminase
+17 more

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ClinolipidExperimental Treatment1 Intervention
Dosing based on American Academy of Pediatrics (AAP), American Academy Society for Parenteral and Enteral Nutrition (ASPEN), European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN)/ European Society for Parenteral and Enteral Nutrition (ESPEN)/ European Society of Paediatric Research (ESPR)/ Chinese Society for Parenteral and Enteral Nutrition (CSPEN) guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.
Group II: IntralipidActive Control1 Intervention
Dosing based on AAP, ASPEN, ESPGHAN/ESPEN/ESPR/CSPEN guidelines. Study treatment will be administered intravenously in the hospital setting from 7 up to 90 days using either a syringe pump or an infusion pump as appropriate for the daily volume of infusate. The flow rate will be prescribed by the Investigator to provide the daily dosage over 20 to 24 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clinolipid
2021
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

Baxter Healthcare CorporationLead Sponsor
313 Previous Clinical Trials
199,649 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How widespread is this research endeavor?

"At this time, the 9 enrolling sites that are part of this trial can be found in Orlando, Provo and New Haven, as well as 6 other cities. To reduce travelling expenses if you decide to participate, select the clinic closest to your home."

Answered by AI

How many participants is this research program accommodating?

"Unfortunately, this medical trial has ended recruitment. It was initially posted on January 22 2021 and its last update occurred on October 10 2022. If you wish to take part in a clinical study, there are two ascorbic acid deficiency research studies and seventeen Clinolipid trials actively seeking patients."

Answered by AI

Are there any other studies which have previously explored the effects of Clinolipid?

"Initial exploration of clinolipid began in 2014 at the University of Rochester Medical Center, and since then 77 trials have been concluded. Currently 17 more live studies are being conducted, with a bulk of these happening around Orlando, Florida."

Answered by AI

Is enrollment still taking place for this trial?

"The information on clinicaltrials.gov suggests that enrollment for this particular trial has ceased. Initially listed on the 22nd of January 2021 and most recently modified on 10th October 2022, it appears that there are no more openings available in this study; however, 19 other trials have open spots presently."

Answered by AI

What purpose does Clinolipid serve in medical treatment?

"Clinolipid is a pharmaceutical remedy for treating parenteral nutrition, supplementing nutrients and counteracting ascorbic acid deprivation."

Answered by AI

Has the FDA given its approval to Clinolipid?

"There is a high level of confidence in Clinolipid's safety, as the drug has already been approved and is now undergoing Phase 4 trials. As such, it received a score of 3."

Answered by AI
~24 spots leftby Mar 2025