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CompletedNCT01364948TopOilTewlUpdated Jun 3, 2011

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

An interventional study of Coconut oil application and No oil application in Trans Epidermal Water Loss (TEWL), sponsored by All India Institute of Medical Sciences, New Delhi. Completed at 1 site in India. Open to participants aged 12 Hours to 168 Hours. Per ClinicalTrials.gov, last updated 2011-06-03.

Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
12 Hours to 168 Hours
Sex
All
01

Study 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. 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

02

Conditions studied

  • Trans Epidermal Water Loss (TEWL)

Keywords

  • Preterm
  • VLBW
  • Coconut Oil application
  • Trans epidermal water loss
  • Weight gain
03

In context

Lead sponsor

All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Hours to 168 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • 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).

    Other: Coconut oil application

  • 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.

    Other: No oil application

Interventions

  • OtherCoconut oil application

    Four ml coconut oil application twice daily for first week

  • OtherNo oil application

    Oil application was not done

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: first 7 days of life

Secondary outcomes

  1. 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.

    Time frame: Weight first 7 days of life and 40 weeks postmenstrual age

  2. 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.

    Time frame: Skin condition Score at day 7 of life

  3. Skin colonization pattern

    The skin swab cultures were sent after 1week of life to assess for skin colonization

    Time frame: Skin colonization pattern at day 7 of life

07

Study locations

1 site
  • All India Institute Of Medical Sciences
    New Delhi, Delhi 110029, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01364948
Lead sponsor
All India Institute of Medical Sciences, New Delhi
First posted
Jun 3, 2011
Start date
Jan 2006
Primary completion
Nov 2006
Completion
Dec 2006
Last update
Jun 3, 2011

Study contacts

Dr Sushma Nangia, MBBS, MD
principal investigator · All India Institute of Medical Sciences, New Delhi

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2005. You cannot join it, but the record below documents what was studied.

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