- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01364948
Effect of Coconut Oil Application in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL) (TopOilTewl)
June 1, 2011 updated by: All India Institute of Medical Sciences, New Delhi
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Delhi
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New Delhi, Delhi, India, 110029
- All India Institute of Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All preterm babies born at the study center with birth weight < 1500gms were eligible for inclusion in the study.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coconut oil application
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).
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Four ml coconut oil application twice daily for first week
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No Intervention: No Oil Application
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.
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Oil application was not done
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trans Epidermal Water Loss(TEWL)
Time Frame: first 7 days of life
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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)
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first 7 days of life
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Weight first 7 days of life and 40 weeks postmenstrual age
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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.
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Weight first 7 days of life and 40 weeks postmenstrual age
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Skin condition Score
Time Frame: Skin condition Score at day 7 of life
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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.
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Skin condition Score at day 7 of life
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Skin colonization pattern
Time Frame: Skin colonization pattern at day 7 of life
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The skin swab cultures were sent after 1week of life to assess for skin colonization
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Skin colonization pattern at day 7 of life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr Sushma Nangia, MBBS, MD, All India Institute of Medical Sciences, New Delhi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 1, 2011
First Posted (Estimate)
June 3, 2011
Study Record Updates
Last Update Posted (Estimate)
June 3, 2011
Last Update Submitted That Met QC Criteria
June 1, 2011
Last Verified
December 1, 2005
More Information
Terms related to this study
Other Study ID Numbers
- A-28/Dec 2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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