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| Name | Class |
|---|---|
| Cloudnine Hospital, Bangalore, India | UNKNOWN |
| University of Cincinnati | OTHER |
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The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.
Purpose and Specific Aims
The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on:
The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coconut oil at 5 mg/Kg body weight twice daily | Experimental | Coconut oil (Parachute Brand) is a marketed product that is routinely used for daily massage after birth for infants in India. An amount of 5 mg/Kg body weight will be applied twice daily by the health care provider from enrollment until discharge, or until day of life 28, whichever occurs first. |
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| No intervention | No Intervention | Subjects assigned to this arm will have their skin gently stroked twice daily for the time that would be required to apply an oil. This will simulate the stroking received by the intervention arm subjects. This will occur from enrollment until discharge, or until day of life 28, whichever occurs first. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coconut oil | Other | Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid |
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| Measure | Description | Time Frame |
|---|---|---|
| Late-onset sepsis rate for intervention versus control | Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life | Day 3 of life until discharge or day of life 28, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Skin erythema | The skin erythema (redness) of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of erythema will be judged using published, validated grading scales. | Day 3 of life until discharge or day of life 28, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vivek Narendran, MD | Contact | 513-636-4200 | vivek.narendran@cchmc.org | |
| Marty Visscher, PhD | Contact | 513-746-5100 | visschmo@ucmail.uc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kishore Kumar, MBBS, MD | Cloudnine Hospital | Principal Investigator |
| Naveen Benakappa, MBBS, MD | Indira Gandhi Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cloudnine Hospital | Recruiting | Bangalore | India |
There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000074263 | Coconut Oil |
| ID | Term |
|---|---|
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 |
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Randomized, single-blind, parallel group, controlled trial
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Subjects will be randomly assigned to receive coconut oil or no treatment using a random number scheme after stratification for gestational age group
| Skin rash | The skin rash of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of rash will be judged using published, validated grading scales. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Skin dryness | The skin dryness of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of dryness/scaling will be judged using published, validated grading scales. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Skin transepidermal water loss | The rate of transepidermal water loss of a site on the outer thigh will be measured as grams/meter2/hour using a standard, closed-chamber instrument known as the Vapometer. This instrument will provide the transepidermal water loss value once the system reaches equilibrium. This method has previously been validated and is used routinely for skin measurements. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Skin surface acidity (pH) | The skin surface acidity of a site on the outer thigh and a site on the buttocks covered by the diaper will be measured using a flat surface electrode device that is calibrated daily to buffers of pH 4 and pH 7. The surface acidity is given in pH units which are the negative log to the base 10 of the hydrogen ion concentration of water placed on the skin by the instrument probe. The instrument is designed for use on the skin and has been validated. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Set of skin surface proteins of known innate immune function | There are proteins in the skin surface layers known to be biomarkers of innate immune function. Each protein will be quantified and reported as picograms of protein per microgram of total protein. The specific proteins are: filaggrin, filaggrin 2, transglutaminase 3, S100A8 (antimicrobial, calcium binding protein), S100A7 (antimicrobial, calcium binding protein), SERPINB3 (cysteine protease inhibitor), SERPINB4 (protease inhibitor), elafin (protease inhibitor) keratins 1, 6A and 6B (structural proteins) and fatty acid elongase 1 (lipid). Levels of each protein will be evaluated together to compare effect of the intervention versus control. Samples from skin surface will be collected using two sequential adhesive tapes (gentle adhesive) placed on the skin sites (thigh, buttocks covered by diaper) for one minute each, removed and stored at -80 deg C until analysis. The proteins will be extracted and analyzed for using standard techniques of tandem mass spectrometry. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Skin Microbiome | Microbiome analyses of neonatal skin and stool to determine the effect of coconut oil versus no treatment on microflora | Day 3 of life until discharge or day of life 28, whichever comes first |
| Chronic lung disease | The incidence of chronic lung disease among the subjects in the intervention (coconut oil) will be compared to the incidence in the no treatment control during the study period. Chronic lung disease will be diagnosed based on the subject's oxygen requirement at 36 weeks corrected age. | Day 3 of life until discharge or day of life 28, whichever comes first |
| Causative Organisms of Sepsis | Sepsis diagnosis includes determination of the organisms to which sepsis was attributed | Day 3 of life until discharge or day of life 28, whichever comes first |
| Necrotizing enterocolitis | The impact of coconut oil versus no treatment on the incidence of necrotizing enterocolitis during the study period | Day 3 of life until discharge or day of life 28, whichever comes first. |
| Prathik B H, MBBS, MD |
| Indira Gandhi Institute of Child Health |
| Principal Investigator |
| Indira Gandhi Institute of Child Health | Withdrawn | Bangalore | India |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Oils |