Trans Epidermal Water LossTEWLNCT01758068
Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life
A study testing Coconut Oil Application in people with Trans Epidermal Water Loss, run by Lady Hardinge Medical College.
Trial summary
The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Read more about this study
- Who is it for?
- Ages 12 hours to 7 days
- Conditions the study is for
- Trans Epidermal Water Loss
- What is being tested?
- Coconut Oil Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Dec 2006
- 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 12 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm babies born at the study center with birth weight < 1500g were eligible for inclusion in the study.
Who cannot join
- Babies with birth weight less than 750 gms at birth
- Babies with major congenital malformations.
- Babies with severe asphyxia, hydrops and shock.
- Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
- Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area)
About this study
Official title: Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.
- Conditions
- Trans Epidermal Water Loss
- Being tested
- Coconut Oil Application
- Keywords
- Preterms, Coconut Oil application, Trans epidermal water loss, Weight gain
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut Oil ApplicationProcedure or surgery
Coconut oil - 4 ml
| Study group | Role | What they receive |
|---|---|---|
| Coconut Oil Application | Experimental | The oil (coconut oil) was applied by the trained nurse to the entire body surface of infant except the face two times a day started as early as possible Four ml of coconut oil was applied using both hands of the caregiver in four strokes starting from the level of clavicles over the chest and abdomen till the groin, from the front of thighs, knee, leg and upto the sole, from above the shoulders over the arm and forearm till the palm continuing medially over the forearm and arm till the axilla and the final stroke was used for the back reaching over the back of the thighs till the heel. Just prior to the first application, and thereafter prior to the subsequent applications the TEWL was recorded using the portable closed chamber evaporimeter. The oil application was continued twice daily (every 12 hrs at the same time as the hour of birth e.g. 11 am and 11pm) till the completion of the seventh day (168 hrs of life).. Receives: Procedure: Coconut Oil Application |
| No Oil Application | No intervention | Babies in this group were not subjected to oil application. TEWL measurement was recorded every 12 hrs for the first week of life, at the same time as the hour of birth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans Epidermal Water Loss(TEWL)
TEWL was measured using evaporimeter(Vapometer, Delfin Technologies limited, Kuopio, Finland) at 12 hours of age and thereafter every 12 hours till first 7 days of life
Measured: first 7 days of life
Secondary outcomes (3)
Weight
The weight of the neonate was recorded at birth and daily during the first week of life. The weight in grams and weight gain in grams/kilogram/day was measured at 40 weeks post conceptional age.
Measured: first 7 days of life and 40 weeks postmenstrual age
Skin condition Score
Skin Condition Score was measured using 'Lane and Drost' Score.This score has 9 scores from 1 to 9, 1 depicting the best skin state and 9 the worst with erythema, blistering \& oozing over the entire area.
Measured: at day 7 of life
Skin colonization pattern
The skin swab cultures were sent after 1week of life to assess for skin colonization
Measured: at day 7 of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trans Epidermal Water LossStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Collaborators
- All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, MD, DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758068
- Sponsor's protocol ID
- AIIMS/06/TEWL
- Acronym
- TEWL
- Status last verified
- Dec 2012
- First submitted
- 23 Dec 2012
- Last updated
- 31 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nangia S, Paul VK, Deorari AK, Sreenivas V, Agarwal R, Chawla D. Topical Oil Application and Trans-Epidermal Water Loss in Preterm Very Low Birth Weight Infants-A Randomized Trial. J Trop Pediatr. 2015 Dec;61(6):414-20. doi: 10.1093/tropej/fmv049. Epub 2015 Sep 3.
PubMed 26338490
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT01758068
- Acronym / sponsor ID
- TEWL / AIIMS/06/TEWL
- Conditions
- Trans Epidermal Water Loss
- Keywords
- Preterms, Coconut Oil application, Trans epidermal water loss, Weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Collaborators
- All India Institute of Medical Sciences
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 31 Dec 2012 (estimated)
- 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 skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut Oil Application | Experimental | Procedure: Coconut Oil ApplicationThe oil (coconut oil) was applied by the trained nurse to the entire body surface of infant except the face two times a day started as early as possible Four ml of coconut oil was applied using both hands of the caregiver in four strokes starting from the level of clavicles over the chest and abdomen till the groin, from the front of thighs, knee, leg and upto the sole, from above the shoulders over the arm and forearm till the palm continuing medially over the forearm and arm till the axilla and the final stroke was used for the back reaching over the back of the thighs till the heel. Just prior to the first application, and thereafter prior to the subsequent applications the TEWL was recorded using the portable closed chamber evaporimeter. The oil application was continued twice daily (every 12 hrs at the same time as the hour of birth e.g. 11 am and 11pm) till the completion of the seventh day (168 hrs of life).. |
| No Oil Application | No intervention | –Babies in this group were not subjected to oil application. TEWL measurement was recorded every 12 hrs for the first week of life, at the same time as the hour of birth. |
Who may qualify
- Ages
- 12 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All preterm babies born at the study center with birth weight < 1500g were eligible for inclusion in the study.
Key exclusion criteria (5 listed)
- Babies with birth weight less than 750 gms at birth
- Babies with major congenital malformations.
- Babies with severe asphyxia, hydrops and shock.
- Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
- Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area)
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 Oil ApplicationCoconut oil - 4 ml | Procedure or surgery | Coconut Oil Application |
Primary outcome
Trans Epidermal Water Loss(TEWL)
Time frame: first 7 days of life
TEWL was measured using evaporimeter(Vapometer, Delfin Technologies limited, Kuopio, Finland) at 12 hours of age and thereafter every 12 hours till first 7 days of life
3 secondary outcomes
Weight
Time frame: first 7 days of life and 40 weeks postmenstrual age
Skin condition Score
Time frame: at day 7 of life
Skin colonization pattern
Time frame: at day 7 of life
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 31 Dec 2012.
- Derived from this study: PubMed 26338490Nangia S, Paul VK, Deorari AK, Sreenivas V, Agarwal R, Chawla D. Topical Oil Application and Trans-Epidermal Water Loss in Preterm Very Low Birth Weight Infants-A Randomized Trial. J Trop Pediatr. 2015 Dec;61(6):414-20. doi: 10.1093/tropej/fmv049. Epub 2015 Sep 3.
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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.
Sushma Nangia, MD, DM principal investigator
All India Institute of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Coconut Oil Application in people with Trans Epidermal Water Loss, run by Lady Hardinge Medical College.
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 1 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 31 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Trans Epidermal Water Loss(TEWL) (time frame: first 7 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758068, which also lists 1 linked publication.
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 31 Dec 2012.