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Trial registered on ANZCTR

Registration number

ACTRN12616000042448

Ethics application status

Approved

Date submitted

18/08/2015

Date registered

19/01/2016

Date last updated

26/04/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Topical application of coconut oil to improve skin condition in very preterm infants- a pilot randomised controlled trial.

Scientific title

Topical application of coconut oil to improve skin condition in very preterm infants

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

skin integrity

Late onset sepsis

preterm birth

Condition category

Condition code

Skin

Dermatological conditions

Reproductive Health and Childbirth

Complications of newborn

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Virgin coconut oil will be sourced from a single supplier in 50 ml aliquots and will be distributed to each participant in individual containers twice weekly to avoid cross contamination . This product is certified organic, rich in lauric acid (~50%) and has been independently tested for lack of contamination with pesticides and absence of microbial growth.
The oil application (5 ml/kg per application, 12 hourly for 3 weeks) by trained nursing staff will commence within 24 hours of admission to provide optimal potential benefit. Strict hand hygiene protocol will be followed. Each application will be completed in 2-3 minutes, involving gentle strokes without massage. To avoid excessive handling, oil application will be timed with routine care procedures.
The oil application will involve 4 steps. Infant in supine position: (1) Apply to front of the trunk starting from level of clavicles down to the groins. (2) Apply to the thighs, knees and feet. (3) Apply to upper limbs starting from the shoulder blades along the posterior of the arms to the back of the hands, and then going back to the shoulders covering the opposite side of the arms. Prone position: (4) Apply starting from the neck to above the nappy area, extending laterally to the flanks and then apply to the back of the lower limbs to the foot. Avoid the scalp, face and intravenous infusion sites.The patients in intervention arm will recieve standard routine care given in the nursery in addition to coconut oil application.Each oil application in intervention arm will be logged in to patients medical charts by the nursing staff to moniter adherance.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

standard care of new born - minimal handling , humidification

Control group

Active

Outcomes

Primary outcome [1]

Proportion of children with improvement in skin integrity
as assessed by the Neonatal skin condition scale (NSCS)

Timepoint [1]

3 weeks of life

Primary outcome [2]

Incidence of local skin irritation and infection as a composite out come and will be assessed as per guidelines given in Neonatal Skin condition scoring(NSCS) as adopted by
Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN).
REFERENCE
AWHONN. Neonatal Skin Care: Evidence-Based Clinical Practice Guideline 3rd ed. Washington USA: Johnson & Johnson; 2007.

Timepoint [2]

Till end of the three week intervention period

Primary outcome [3]

Feasibility of the coconut oil application to the enrolled infants as per study protocol
.Measured as the proportion of preterm infants in which topical coconut oil could be applied successfully for three weeks.

Timepoint [3]

End of three weeks of intervention

Secondary outcome [1]

Incidence of late onset sepsis, based on positive blood culture 72 hours after birth

Timepoint [1]

72 hours after birth

Secondary outcome [2]

Mortality-
Death upto 37 weeks corrected gestation

Timepoint [2]

37 weeks corrected gestation

Secondary outcome [3]

Time to regain birth weight using calibrated digital scales

Timepoint [3]

From birth until birthweight regained

Secondary outcome [4]

Discharge weight using calibrated digital scales

Timepoint [4]

at discharge from NICU

Secondary outcome [5]

Duration of hospital stay as per the medical records

Timepoint [5]

from birth until discharge from hospital

Secondary outcome [6]

Total duration of ventilation required from birth, outcome assessed using medical records of nursing charts

Timepoint [6]

Duration from endotracheal Intubation until tiime of self ventilation in air

Secondary outcome [7]

Duration of oxygen,outcome assessed using medical records of nursing charts

Timepoint [7]

Total duration from birth until no oxygen supplemention required..
The Outcome number 6 will involve total duration of ventilaion (invaive and non invasive), while this outcome will measure the total duration of oxygen required from birth ( including other methods like low flow oxygen)

Secondary outcome [8]

Incidence of Retinopathy of prematurity worst stage .Outcome assessed using regular opthalmological examinations using retcam and direct opthalmoscopy by opthmalmologist

Timepoint [8]

ROP screening till discharge from NICU

Secondary outcome [9]

Incidence of Haemodynamically significant patent ductus arteriosus, Outcome assessed using regular functional echocardiography performed by neonatologist.

Timepoint [9]

First 10 days after intervention commencement

Secondary outcome [10]

Incidence of Intraventricular haemorrhage(IVH).Outcome assessed by regular head ultrasound performed routinely by radiologist in department on day 1, day7 and day 28

Timepoint [10]

day1,7 and day28 of life

Secondary outcome [11]

Incidence of necrotizing enterocolitis. Using clinical and radiological parameters and applying Bell classification for stratifying grades of severity.

Timepoint [11]

Till discharge from hospital.

Secondary outcome [12]

serum levels of lauric acid and monolaurin pre and post intervention, measured as a composite outcome

Timepoint [12]

Before commencement of intervention till 10 days after intervention( within 72 hours of finishing 10days)

Secondary outcome [13]

Type of skin bacterial colonization

Timepoint [13]

skin swabs taken weekly till three weeks after starting intervention.

Eligibility

Key inclusion criteria

(1) Gestation <30 weeks, (2) Postnatal age <24 hours, (3) Informed parental consent

Minimum age

1 Hours

Maximum age

24 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) Presence of major congenital malformation/s requiring surgery, (2) Congenital skin abnormality or signs of skin infection, (3) life-threatening illness during the first 24h of life (as certified by the consulting physician)

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Based on the data from studies in Low and middle income countires, recruitment of 60 very preterm infants (30 each in intervention and control arm) assures 80% power to detect a 1 standard deviation difference in the skin integrity score in the intervention versus control arm infants in this pilot RCT. An additional 12 infants are required to cover for potential 20% loss to follow up. A total of 72 (36 in each arm) very preterm infants will therefore be enrolled

Approach to analysis: The analysis will be based on the intention to treat principle.

Statistical methods.
Group outcomes will be summarized using medians, interquartile ranges and ranges for continuous outcomes. Categorical outcomes will be summarized using frequency distributions. Univariate comparisons for continuous data will be made using Mann Whitney tests and for categorical data using Chi-square or Fisher exact tests. All tests will be two-sided, and a p-value<0.05 will be considered statistically significant for the primary analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

22/02/2016

Actual

24/03/2016

Date of last participant enrolment

Anticipated

Actual

31/10/2016

Date of last data collection

Anticipated

Actual

21/11/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Other

Name [1]

King Edward Memorial Hospital

Address [1]

374 ,Bagot road Subiaco, WA 6008

Country [1]

Australia

Primary sponsor type

Hospital

Name

King Edward Memorial Hospital

Address

374 ,Bagot road Subiaco, WA 6008

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Tobias Strunk

Address [1]

Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374,Bagot road,Subiaco,WA ,6008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women and New born Health service Human Research Ethics Committee

Ethics committee address [1]

Women and Newborn Health Service
O Block, KEMH, Subiaco, WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2015

Approval date [1]

24/11/2015

Ethics approval number [1]

2015191EW

Summary

Brief summary

Project’s aim(s): We aim to assess the safety and efficacy of topical application of coconut oil in improving skin integrity in very preterm infants (<30 weeks)
Justification: The skin of a premature baby is delicate. Loss of body water through the thin skin can cause dehydration, weight loss, dry skin and increased risk of infections. The skin care of premature babies includes minimal handling, humidification in the incubator, and topical application of creams and various natural oils. Studies have shown that topical application of creams increase the risk of infections. Studies from developing countries have shown that topical application of natural oils improves skin condition, causes weight gain, and reduces the risk of infection in preterm infants. Also, Coconut oil has large amount of fats with antibacterial properties. None of these studies reported any significant side effects of topical application of coconut oil. However these trials did not involve enough number of very premature babies. Considering that it is a simple and inexpensive option. We plan to conduct a study of topical application of coconut oil for improving skin condition of very premature babies born before 30 weeks. 
Participant group(s): Participants will be the preterm infants <30 weeks (Coconut oil+ standard treatment {minimal handling, high humidity}-36, Standard treatment-36)
Project design and methods: This study will be a randomized controlled trial. The baby’s skin will be assessed by a trained nurse (using the routine protocol for skin assessment in hospital ) within 24 hours of admission and then on day 7, 14 and 21 after birth. Coconut oil will be applied (starting within 24 hours of admission in nursery) to the baby’s skin using gentle strokes without excessive pressure and avoiding massage. The application will not cover the face, head and drip site .Oil will be provided in separate tubes for each baby and the left over will be discarded after each application, to minimize the risk of infection. We will collect information about the progress of the baby (nutritional parameters and impact on various complications of prematurity). Skin surface swabs (from ear lobes, axilla and groin) would be taken weekly to monitor the change in bacterial flora on the skin. weekly weight gain per kg body weight during the study intervention and until discharge or death after first admission. Two blood samples of 500 microlitre each for assessment of plasma Lauric acid and Monolaurin levels will be taken from the infants veins prior to study intervention and after 10 days(within 72 hours of collection).Whenever possible, blood sampling will be combined with sampling for routine blood tests. No more than 2 attempts at blood collection will be performed.
Expected outcomes: Based on our hypothesis we expect that coconut oil application in very preterm babies will be safe and would result in improvement in their skin condition and reduce the incidence of infections.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Sanjay Patole

Address

Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

sanjay.patole@health.wa.gov.au

Contact person for public queries

Name

Sameer Pupala

Address

Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

sameer.pupala@health.wa.gov.au

Contact person for scientific queries

Name

Sameer Pupala

Address

Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008

Country

Australia

Phone

+61893402222

Fax

sameer.pupala@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Topical Coconut Oil in Very Preterm Infants: An Open-Label Randomised Controlled Trial.	2018	https://dx.doi.org/10.1159/000480538
Embase	Skin-Microbiome Assembly in Preterm Infants during the First Three Weeks of Life and Impact of Topical Coconut Oil Application.	2023	https://dx.doi.org/10.3390/ijms242316626

N.B. These documents automatically identified may not have been verified by the study sponsor.

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