- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01758068
Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
December 23, 2012 updated by: Sushma Nangia, M.D., Lady Hardinge Medical College
Effect of Topical Oil Application on Trans-Epidermal Water Loss in Preterm Infants - A Randomized Clinical Trail
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 hours to 1 week (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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)..
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
first 7 days of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
first 7 days of life and 40 weeks postmenstrual 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.
|
at day 7 of life
|
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
|
at day 7 of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sushma Nangia, MD, DM, All India Institute of Medical Sciences, New Delhi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
September 1, 2006
Study Completion (ACTUAL)
December 1, 2006
Study Registration Dates
First Submitted
December 23, 2012
First Submitted That Met QC Criteria
December 23, 2012
First Posted (ESTIMATE)
December 31, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 31, 2012
Last Update Submitted That Met QC Criteria
December 23, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- AIIMS/06/TEWL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trans Epidermal Water Loss
-
Atlantia Food Clinical TrialsCompleted
-
Higher School of Applied Sciences (VIST)European Regional Development Fund; Valens Int. d.o.o., Slovenija; Ministry of...CompletedWrinkles | Skin Hydration | Trans Epidermal Water Loss (TEWL) | Dermis Density | Dermis ThicknessSlovenia
-
VIST - Faculty of Applied SciencesSlovenian Research Agency; Tosla d.o.o.CompletedWrinkles | Skin Elasticity | Skin Hydration | Trans Epidermal Water Loss (TEWL) | Dermis Density | Dermis Thickness | Skin TextureSlovenia
-
All India Institute of Medical Sciences, New DelhiCompletedTrans Epidermal Water Loss (TEWL)India
-
L'OrealNestléCompletedSkin Sensitivity | Trans-epidermal Water Loss | Clinical Score | Assessment of Skin Moisturization Factors | Assessment of Serum Immune-regulatory Cytokine | Evaluation of Intestinal Flora CompositionFrance
-
University of PittsburghAmerican Orthotic and Prosthetic AssociationCompletedTrans-tibial Limb LossUnited States
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...RecruitingDiabetic Foot | Diabetic Foot Infection | Chronic Wounds | Biofilm Infection | Trans-epidermal Water Loss (TEWL)United States
-
Shannaz Nadia YusharyahyaPT. Kimia Farma (Persero) Tbk; Ministry of Education, Culture, Research, and...CompletedSkin Aging | Transepidermal Water LossIndonesia
-
Ain Shams Maternity HospitalUnknownVaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal MyomectomyEgypt
-
ESM Technologies, LLCEnrolling by invitationSkin Elasticity | Skin Hydration | Hair Health | Skin Barrier to Water Loss | Fingernail HealthUnited States
Clinical Trials on Coconut Oil Application
-
All India Institute of Medical Sciences, New DelhiCompletedTrans Epidermal Water Loss (TEWL)India
-
Bournemouth UniversityDorset HealthCare University NHS Foundation TrustCompletedMetabolic Ketosis | Cognitive Impairments, MildUnited Kingdom
-
Université de SherbrookeCompleted
-
Gadjah Mada UniversityUnknownCoronavirus InfectionsIndonesia
-
NYU Langone HealthCompletedPsoriasis | Psoriatic ArthritisUnited States
-
Universidade Federal do Rio de JaneiroConselho Nacional de Desenvolvimento Científico e Tecnológico; Rio de Janeiro...Unknown
-
Rowan UniversitySuspendedMuscle Strength | Neuromuscular Function | Fat-free MasssUnited States
-
National University, SingaporeClinical Nutrition Research Centre, SingaporeCompletedCarotenoidsSingapore
-
Malaysia Palm Oil BoardInternational Medical University (IMU), Kuala Lumpur,MalaysiaCompleted
-
University of ReadingCompletedCardiovascular Risk FactorUnited Kingdom