Late-Onset Neonatal SepsisNCT04842786
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
A study testing Coconut oil in people with Late-Onset Neonatal Sepsis, run by Children's Hospital Medical Center, Cincinnati at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Late-Onset Neonatal Sepsis
- What is being tested?
- Coconut oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2021to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants 24-36 weeks gestational age
- Full-term infants 37-42 weeks gestational age
- Less than 48 hours of age at enrollment
- Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
- Expected to be in the neonatal intensive care unit for at least 4 days after enrollment
- Able to tolerate study procedures as described
- Parent/guardian willing to provide written informed consent
Who cannot join
- Medically unstable
- Parent/guardian unable to provide written informed consent
- Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa
- Presence of major congenital anomalies
- Infants undergoing surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 incidence of neonatal late onset culture positive sepsis
- Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
- Biomarkers of neonatal innate immune function
- Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.
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.
- Conditions
- Late-Onset Neonatal Sepsis
- Being tested
- Coconut oil
- Keywords
- late-onset neonatal sepsis, premature infant, full-term infant, skin, skin barrier, biomarker, stratum corneum, skin surface acidity (pH), transepidermal water loss, imaging, d'squame tape, microbiome, coconut oil
- Medical subject headings
- Neonatal Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilOther
Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Coconut oil |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 3 of life until discharge or day of life 28, whichever occurs first
Secondary outcomes (10)
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.
Measured: Day 3 of life until discharge or day of life 28, whichever comes first
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 3 of life until discharge or day of life 28, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 May 2021
- Primary completion15 Nov 2025
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late-Onset Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, parallel group, controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Cloudnine Hospital, Bangalore, India, University of Cincinnati
- Responsible party
- Principal investigator, Vivek Narendran, MD, Children's Hospital Medical Center, Cincinnati
- Investigators
- Kishore Kumar, MBBS, MD, Principal investigator, Cloudnine HospitalNaveen Benakappa, MBBS, MD, Principal investigator, Indira Gandhi Institute of Child HealthPrathik B H, MBBS, MD, Principal investigator, Indira Gandhi Institute of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842786
- Sponsor's protocol ID
- 2020-0487
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Coconut Oil Application and Incidence of Sepsis in Neonates
- ClinicalTrials.gov ID
- NCT04842786
- Acronym / sponsor ID
- 2020-0487
- Conditions
- Late-Onset Neonatal Sepsis
- Keywords
- late-onset neonatal sepsis, premature infant, full-term infant, skin, skin barrier, biomarker, stratum corneum, skin surface acidity (pH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Cloudnine Hospital, Bangalore, India, University of Cincinnati
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 incidence of neonatal late onset culture positive sepsis
- Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
- Biomarkers of neonatal innate immune function
- Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blind, parallel group, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Coconut oil at 5 mg/Kg body weight twice daily | Experimental | Other: Coconut oilCoconut 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. |
| 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. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Premature infants 24-36 weeks gestational age
- Full-term infants 37-42 weeks gestational age
- Less than 48 hours of age at enrollment
- Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
- Expected to be in the neonatal intensive care unit for at least 4 days after enrollment
Key exclusion criteria (5 listed)
- Medically unstable
- Parent/guardian unable to provide written informed consent
- Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa
- Presence of major congenital anomalies
- Infants undergoing surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut oilCoconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid | Other | Coconut oil at 5 mg/Kg body weight twice daily |
Primary outcome
Late-onset sepsis rate for intervention versus control
Time frame: Day 3 of life until discharge or day of life 28, whichever occurs first
Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life
10 secondary outcomes
Skin erythema
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Skin rash
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Skin dryness
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Skin transepidermal water loss
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Skin surface acidity (pH)
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Set of skin surface proteins of known innate immune function
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Skin Microbiome
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Chronic lung disease
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Causative Organisms of Sepsis
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first
Necrotizing enterocolitis
Time frame: Day 3 of life until discharge or day of life 28, whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kishore Kumar, MBBS, MD principal investigator
Cloudnine Hospital
Naveen Benakappa, MBBS, MD principal investigator
Indira Gandhi Institute of Child Health
Prathik B H, MBBS, MD principal investigator
Indira Gandhi Institute of Child Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil in people with Late-Onset Neonatal Sepsis, run by Children's Hospital Medical Center, Cincinnati at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late-onset sepsis rate for intervention versus control (time frame: Day 3 of life until discharge or day of life 28, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.