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

NCT ID: NCT01364948

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-12-31

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. 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

Conditions

Trans Epidermal Water Loss (TEWL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Coconut oil application

Intervention Type: OTHER

Four ml coconut oil application twice daily for first week

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.

Group Type: NO_INTERVENTION

No oil application

Intervention Type: OTHER

Oil application was not done

Interventions

Coconut oil application

Four ml coconut oil application twice daily for first week

Intervention Type: OTHER

No oil application

Oil application was not done

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 12 Hours
• Maximum Eligible Age: 168 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Division of Neonatology, Department of Pediatrics, AIIMS, New Delhi, India

Principal Investigators

Dr Sushma Nangia, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

A-28/Dec 2005

Identifier Type: -

Identifier Source: org_study_id