We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758068
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : December 31, 2012
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Trans Epidermal Water Loss Procedure: Coconut Oil Application Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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 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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Hours to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

All preterm babies born at the study center with birth weight < 1500g were eligible for inclusion in the study.

Exclusion Criteria:

  1. Babies with birth weight less than 750 gms at birth
  2. Babies with major congenital malformations.
  3. Babies with severe asphyxia, hydrops and shock.
  4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
  5. 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)

Information from the National Library of Medicine

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

Sponsors and Collaborators
Lady Hardinge Medical College
All India Institute of Medical Sciences, New Delhi
Layout table for investigator information
Principal Investigator: Sushma Nangia, MD, DM All India Institute of Medical Sciences, New Delhi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sushma Nangia, M.D., Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01758068    
Other Study ID Numbers: AIIMS/06/TEWL
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: December 31, 2012
Last Verified: December 2012
Keywords provided by Sushma Nangia, M.D., Lady Hardinge Medical College:
Coconut Oil application
Trans epidermal water loss
Weight gain