Trial Review

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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] 287306 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
skin integrity
 295943 0
Late onset sepsis 296111 0
preterm birth 296596 0
Condition category
Condition code
Skin 296211 296211 0 0
Dermatological conditions
Reproductive Health and Childbirth 296212 296212 0 0
Complications of newborn
Infection 296839 296839 0 0
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] 292628 0
Prevention
Intervention code [2] 293132 0
Treatment: Other
Comparator / control treatment
standard care of new born - minimal handling , humidification
Control group
Active

Outcomes
Primary outcome [1] 295881 0
Proportion of children with improvement in skin integrity
as assessed by the Neonatal skin condition scale (NSCS)
Timepoint [1] 295881 0
3 weeks of life
Primary outcome [2] 296091 0
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] 296091 0
Till end of the three week intervention period
Primary outcome [3] 296092 0
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] 296092 0
End of three weeks of intervention
Secondary outcome [1] 316810 0
Incidence of late onset sepsis, based on positive blood culture 72 hours after birth
Timepoint [1] 316810 0
72 hours after birth
Secondary outcome [2] 317465 0
Mortality-
Death upto 37 weeks corrected gestation
Timepoint [2] 317465 0
37 weeks corrected gestation
Secondary outcome [3] 317466 0
Time to regain birth weight using calibrated digital scales
Timepoint [3] 317466 0
From birth until birthweight regained
Secondary outcome [4] 317468 0
Discharge weight using calibrated digital scales
Timepoint [4] 317468 0
at discharge from NICU
Secondary outcome [5] 317469 0
Duration of hospital stay as per the medical records
Timepoint [5] 317469 0
from birth until discharge from hospital
Secondary outcome [6] 317470 0
Total duration of ventilation required from birth, outcome assessed using medical records of nursing charts
Timepoint [6] 317470 0
Duration from endotracheal Intubation until tiime of self ventilation in air
Secondary outcome [7] 317471 0
Duration of oxygen,outcome assessed using medical records of nursing charts
Timepoint [7] 317471 0
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] 317472 0
Incidence of Retinopathy of prematurity worst stage .Outcome assessed using regular opthalmological examinations using retcam and direct opthalmoscopy by opthmalmologist
Timepoint [8] 317472 0
ROP screening till discharge from NICU
Secondary outcome [9] 317473 0
Incidence of Haemodynamically significant patent ductus arteriosus, Outcome assessed using regular functional echocardiography performed by neonatologist.
Timepoint [9] 317473 0
First 10 days after intervention commencement
Secondary outcome [10] 317474 0
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] 317474 0
day1,7 and day28 of life
Secondary outcome [11] 317475 0
Incidence of necrotizing enterocolitis. Using clinical and radiological parameters and applying Bell classification for stratifying grades of severity.
Timepoint [11] 317475 0
Till discharge from hospital.
Secondary outcome [12] 317476 0
serum levels of lauric acid and monolaurin pre and post intervention, measured as a composite outcome
Timepoint [12] 317476 0
Before commencement of intervention till 10 days after intervention( within 72 hours of finishing 10days)
Secondary outcome [13] 317477 0
Type of skin bacterial colonization
Timepoint [13] 317477 0
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?
No
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
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4220 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 10187 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 291873 0
Other
Name [1] 291873 0
King Edward Memorial Hospital
Country [1] 291873 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
374 ,Bagot road Subiaco, WA 6008
Country
Australia
Secondary sponsor category [1] 290537 0
None
Name [1] 290537 0
Address [1] 290537 0
Country [1] 290537 0
Other collaborator category [1] 278621 0
Individual
Name [1] 278621 0
Dr Tobias Strunk
Address [1] 278621 0
Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374,Bagot road,Subiaco,WA ,6008
Country [1] 278621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293380 0
Women and New born Health service Human Research Ethics Committee
Ethics committee address [1] 293380 0
Women and Newborn Health Service
O Block, KEMH, Subiaco, WA 6008
Ethics committee country [1] 293380 0
Australia
Date submitted for ethics approval [1] 293380 0
01/09/2015
Approval date [1] 293380 0
24/11/2015
Ethics approval number [1] 293380 0
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 59634 0
Prof Sanjay Patole
Address 59634 0
Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008
Country 59634 0
Australia
Phone 59634 0
+61893402222
Fax 59634 0
Email 59634 0
[email protected]
Contact person for public queries
Name 59635 0
Dr Sameer Pupala
Address 59635 0
Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008
Country 59635 0
Australia
Phone 59635 0
+61893402222
Fax 59635 0
Email 59635 0
[email protected]
Contact person for scientific queries
Name 59636 0
Dr Sameer Pupala
Address 59636 0
Neonatal Clinical Care Unit, King Edward Memorial Hospital for Women
374, Bagot road, Subiaco, WA 6008
Country 59636 0
Australia
Phone 59636 0
+61893402222
Fax 59636 0
Email 59636 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseTopical Coconut Oil in Very Preterm Infants: An Open-Label Randomised Controlled Trial.2018https://dx.doi.org/10.1159/000480538
EmbaseSkin-Microbiome Assembly in Preterm Infants during the First Three Weeks of Life and Impact of Topical Coconut Oil Application.2023https://dx.doi.org/10.3390/ijms242316626
N.B. These documents automatically identified may not have been verified by the study sponsor.