NCT01364948

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
Last Updated

June 3, 2011

Status Verified

December 1, 2005

Enrollment Period

10 months

First QC Date

June 1, 2011

Last Update Submit

June 1, 2011

Conditions

Trans Epidermal Water Loss (TEWL)

Keywords

PretermVLBWCoconut Oil applicationTrans epidermal water lossWeight gain

Outcome Measures

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)

    first 7 days of life

Secondary Outcomes (3)

  • Weight

    Weight first 7 days of life and 40 weeks postmenstrual age

  • Skin condition Score

    Skin condition Score at day 7 of life

  • Skin colonization pattern

    Skin colonization pattern at day 7 of life

Study Arms (2)

Coconut oil application

EXPERIMENTAL

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 Oil Application

NO INTERVENTION

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

Coconut oil applicationOTHER

Four ml coconut oil application twice daily for first week

Coconut oil application
No oil applicationOTHER

Oil application was not done

No Oil Application

Eligibility Criteria

Age12 Hours - 168 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Premature BirthWeight Gain

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Sushma Nangia, MBBS, MD

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

January 1, 2006

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

June 3, 2011

Record last verified: 2005-12

Locations

IN(1)