Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
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|ClinicalTrials.gov Identifier: NCT01758068|
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Trans Epidermal Water Loss||Procedure: Coconut Oil Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||December 2006|
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 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)..
Procedure: Coconut Oil Application
Coconut oil - 4 ml
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.
- 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
- Weight [ Time Frame: first 7 days of life and 40 weeks postmenstrual age ]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.
- Skin condition Score [ Time Frame: at day 7 of life ]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.
- Skin colonization pattern [ Time Frame: at day 7 of life ]The skin swab cultures were sent after 1week of life to assess for skin colonization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758068
|Principal Investigator:||Sushma Nangia, MD, DM||All India Institute of Medical Sciences, New Delhi|