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Clinical Trials/NCT01758068
NCT01758068
Completed
Not Applicable

Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail

Lady Hardinge Medical College0 sites74 target enrollmentNovember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trans Epidermal Water Loss
Sponsor
Lady Hardinge Medical College
Enrollment
74
Primary Endpoint
Trans Epidermal Water Loss(TEWL)
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
December 2006
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sushma Nangia, M.D.

Professor

Lady Hardinge Medical College

Eligibility Criteria

Inclusion Criteria

  • All preterm babies born at the study center with birth weight \< 1500g 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)

Outcomes

Primary Outcomes

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 Outcomes

  • Weight(first 7 days of life and 40 weeks postmenstrual age)
  • Skin condition Score(at day 7 of life)
  • Skin colonization pattern(at day 7 of life)

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