Trans Epidermal Water Loss (TEWL)TopOilTewlNCT01364948
Effect of Coconut Oil Application in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
A study testing Coconut oil application and No oil application in people with Trans Epidermal Water Loss (TEWL), run by All India Institute of Medical Sciences at 1 site in India.
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 to 168 hours
- Conditions the study is for
- Trans Epidermal Water Loss (TEWL)
- What is being tested?
- Coconut oil application and No oil application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2006to 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 to 168 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm babies born at the study center with birth weight < 1500gms 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
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Effect of Topical Oil Application on Trans-epidermal Water Loss (TEWL) in Preterm Very Low Birth Weight (VLBW) Infants - A Randomized Clinical Trial
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. Oil application on the skin can act as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut oil, often used for traditional massage of babies by Indian communities, is culturally acceptable and 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 (TEWL)
- Being tested
- Coconut oil application, No oil application
- Keywords
- Preterm, VLBW, Coconut Oil application, Trans epidermal water loss, Weight gain
- Medical subject headings
- Premature Birth, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oil applicationOther
Four ml coconut oil application twice daily for first week
No oil applicationOther
Oil application was not done
| 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 starting at 12 hrs of life. Four ml of coconut oil was applied using both hands of the caregiver in four strokes. First stroke was from the clavicles over the chest and abdomen till the groin, second from the front of thighs over the knee and leg upto the sole, the third one from 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, starting from the upper back, continuing 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: Other: 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. Receives: Other: No oil application |
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 during the first week of life (168 hrs 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: Weight 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: Skin condition Score at day 7 of life
Skin colonization pattern
The skin swab cultures were sent after 1week of life to assess for skin colonization
Measured: Skin colonization pattern 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 posted3 Jun 2011 (estimated)
- Study startJan 2006
- Primary completionNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans Epidermal Water Loss (TEWL)Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Dr Sushma Nangia, MBBS, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364948
- Sponsor's protocol ID
- A-28/Dec 2005
- Acronym
- TopOilTewl
- Status last verified
- Dec 2005
- First submitted
- 1 Jun 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. 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 (TEWL) in Preterm Very Low Birth Weight (VLBW) Infants - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01364948
- Acronym / sponsor ID
- TopOilTewl / A-28/Dec 2005
- Conditions
- Trans Epidermal Water Loss (TEWL)
- Keywords
- Preterm, VLBW, Coconut Oil application, Trans epidermal water loss, Weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 3 Jun 2011 (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. Oil application on the skin can act as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut oil, often used for traditional massage of babies by Indian communities, is culturally acceptable and Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut oil application | Experimental | Other: 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 starting at 12 hrs of life. Four ml of coconut oil was applied using both hands of the caregiver in four strokes. First stroke was from the clavicles over the chest and abdomen till the groin, second from the front of thighs over the knee and leg upto the sole, the third one from 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, starting from the upper back, continuing 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 | Other: No oil applicationBabies 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 to 168 hours
- 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 < 1500gms 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 applicationFour ml coconut oil application twice daily for first week | Other | Coconut oil application |
| No oil applicationOil application was not done | Other | No 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 during the first week of life (168 hrs of life)
3 secondary outcomes
Weight
Time frame: Weight first 7 days of life and 40 weeks postmenstrual age
Skin condition Score
Time frame: Skin condition Score at day 7 of life
Skin colonization pattern
Time frame: Skin colonization pattern 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 3 Jun 2011.
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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.
Dr Sushma Nangia, MBBS, MD principal investigator
All India Institute of Medical Sciences
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 application and No oil application in people with Trans Epidermal Water Loss (TEWL), run by All India Institute of Medical Sciences 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 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 3 Jun 2011. 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?
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?
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 3 Jun 2011.