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

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01364948
First received: June 1, 2011
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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


Condition Intervention
Trans Epidermal Water Loss (TEWL)
Other: Coconut oil application
Other: No oil application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Trans Epidermal Water Loss(TEWL) [ Time Frame: first 7 days of life ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Weight [ Time Frame: Weight first 7 days of life and 40 weeks postmenstrual age ] [ Designated as safety issue: No ]
    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: Skin condition Score at day 7 of life ] [ Designated as safety issue: No ]
    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: Skin colonization pattern at day 7 of life ] [ Designated as safety issue: No ]
    The skin swab cultures were sent after 1week of life to assess for skin colonization


Enrollment: 74
Study Start Date: January 2006
Study Completion Date: December 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Four ml coconut oil application twice daily for first week
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
Oil application was not done

  Eligibility

Ages Eligible for Study:   up to 168 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All preterm babies born at the study center with birth weight < 1500gms 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364948

Locations
India
All India Institute Of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Dr Sushma Nangia, MBBS, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Dr Sushma Nangia, Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi, India
ClinicalTrials.gov Identifier: NCT01364948     History of Changes
Other Study ID Numbers: A-28/Dec 2005
Study First Received: June 1, 2011
Last Updated: June 1, 2011
Health Authority: India: Institutional Review Board- AIIMS

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Preterm
VLBW
Coconut Oil application
Trans epidermal water loss
Weight gain

ClinicalTrials.gov processed this record on October 19, 2014