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Organic, Unrefined Coconut Oil for Contact Dermatitis
N/A
Waitlist Available
Research Sponsored by Genesis Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Babies admitted to the Genesis NICU
Anticipated stay in the NICU is ≥ 48 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once, at hospital discharge, an average of 2 weeks
Awards & highlights
Study Summary
This study is evaluating whether coconut oil is safe and effective for the prevention and treatment of diaper dermatitis in NICU babies.
Eligible Conditions
- Contact Dermatitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once, at hospital discharge, an average of 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once, at hospital discharge, an average of 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of adverse events
The number of days free from diaper dermatitis
Secondary outcome measures
The level of parent satisfaction with the diaper dermatitis treatment used
Side effects data
From 2019 Phase 3 trial • 80 Patients • NCT0182971139%
Oedema peripheral
35%
Nausea
33%
Headache
33%
Fatigue
28%
Pyrexia
24%
Hypocalcaemia
24%
Hypophosphataemia
23%
Constipation
21%
Alanine aminotransferase increased
21%
Anaemia
21%
Diarrhoea
20%
Lymphocyte count decreased
20%
Hypoalbuminaemia
19%
Aspartate aminotransferase increased
19%
Chills
18%
Vomiting
16%
Arthralgia
16%
Hypokalaemia
15%
Hypertension
15%
Back pain
15%
Pain in extremity
14%
Decreased appetite
14%
Face oedema
14%
Myalgia
13%
Abdominal distension
13%
Asthenia
11%
Anxiety
11%
Hyponatraemia
11%
Platelet count decreased
10%
Dyspnoea
10%
Dizziness
10%
Insomnia
10%
Blood creatinine increased
10%
Hyperglycaemia
10%
White blood cell count decreased
9%
Cough
9%
Paraesthesia
9%
Vision blurred
9%
Abdominal pain
8%
Hypotension
8%
Oropharyngeal pain
8%
Pruritus
8%
Haptoglobin decreased
8%
Hyperkalaemia
8%
Hypomagnesaemia
8%
Weight increased
8%
Haemolytic uraemic syndrome
8%
Sinus tachycardia
8%
Dry eye
6%
Infusion related reaction
6%
Haematuria
6%
Nasal congestion
6%
Dysgeusia
6%
Upper respiratory tract infection
6%
Pleural effusion
6%
Blood bilirubin increased
6%
Neutrophil count decreased
6%
Flatulence
6%
Musculoskeletal pain
5%
Rash maculo-papular
5%
Flushing
5%
Rash
5%
Capillary leak syndrome
5%
Non-cardiac chest pain
5%
Blood alkaline phosphatase increased
5%
Hypernatraemia
5%
Neutropenia
5%
Cataract
5%
Abdominal pain upper
5%
Dyspepsia
5%
Oedema
5%
Peripheral swelling
5%
Nasopharyngitis
5%
Rhinitis
5%
Sinusitis
5%
Musculoskeletal chest pain
3%
Hypoxia
3%
Febrile neutropenia
1%
Tachypnoea
1%
Multiple organ dysfunction syndrome
1%
Pain
1%
Clostridium difficile colitis
1%
Erysipelas
1%
Rhabdomyolysis
1%
Pharyngeal cyst
1%
Respiratory failure
1%
Left ventricular dysfunction
1%
Neutropenic colitis
1%
Glioblastoma
1%
Mental status changes
1%
Acute kidney injury
1%
Renal failure
1%
Lung infection
1%
Pneumonia
1%
Pneumonia fungal
1%
Sepsis syndrome
1%
Infection
1%
Septic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moxetumomab Pasudotox 40 µg/kg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Coconut OilExperimental Treatment1 Intervention
Participants in this group will receive a generous layer of organic, unrefined coconut oil applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
Group II: Standard of CareActive Control1 Intervention
Participants in this group will receive the standard of care for preventing and treating diaper dermatitis at Genesis. This includes no treatment until a diaper dermatitis appears. If diaper dermatitis appears, participants will receive a generous layer of Medline Remedy Phytoplex Z-Guard Skin Protectant applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
Find a Location
Who is running the clinical trial?
Genesis Health SystemLead Sponsor
1 Previous Clinical Trials
71 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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