Topical Emollient Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
ClinicalTrials.gov Identifier:
NCT01396642
First received: July 7, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Almost all (99%) of the neonatal deaths occur in lower and middle income countries. Most of these deaths are attributable to prematurity and infection. With the increasing rate of premature births in some settings, the mortality rate of over 50% among preterm babies in some of the developing countries require inexpensive hospital-based strategies to prevent fatal infections in newborns of these countries. As most of the deaths in preterm neonates are attributable to their vulnerability of infection, a potential low cost intervention like topical emollient therapy can be effectively directed to reduce infection related mortality and morbidity in the developing countries. Topical emollient therapy reduces the rate of infection by enhancing the skin barrier function, thus reducing trans-epidermal water loss consequently conserving heat and energy to promote growth.

The broad goal of the study is to improve the survival rate of hospitalized preterm neonates in the developing countries by decreasing the incidence of infection using low-cost interventions.

HYPOTHESIS:

It is hypothesized that topical emollient therapy with coconut oil twice a day till 28th day of life in hospitalized preterm neonates reduces the incidence proportion of hospital acquired infection by 40% 15 as compared to routine skin care. For the secondary objective it is hypothesized that the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day18 more as compared to the weight gain in the routine skin care group.


Condition Intervention
Blood Stream Infection
Other: Topical Emollient

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • Hospital Acquired Blood Stream Infection [ Time Frame: 28 days of life ] [ Designated as safety issue: No ]
    Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission.


Secondary Outcome Measures:
  • Weight Gain [ Time Frame: 28th Day of Life ] [ Designated as safety issue: No ]

Enrollment: 258
Study Start Date: July 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Topical Emollient
Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
Other: Topical Emollient
Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
No Intervention: Routine Skin Care
Neonates in this group will receive routine skin care as per unit protocol

Detailed Description:

Research question:

  1. The primary research question to be addressed via this study is whether the prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, effective in reducing the incidence proportion of hospital acquired infection among preterm neonates by 40% as compared to the routine skin care.
  2. The secondary research question is whether the weight gain in the neonates receiving prophylactic application of emollient, which is coconut oil twice a day till 28th day of life, is at least 2g/kg/day more as compared to the weight gain in the routine skin care group.

Objectives: This study has the following primary objectives:

  1. To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates.

    The secondary objective is:

  2. To compare the weight gain among the two groups of neonates.
  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any preterm neonates (>26 weeks and < 37 weeks of gestation by maternal dates)
  2. Birth weight of at least 750 gm
  3. Age ≤72 hours of life
  4. Baseline blood cultures obtained
  5. Expected survival > 48 hours (based on the clinical judgment by the physicians)

Exclusion Criteria:

  1. Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
  2. Neonate within first 24 hours of critical care
  3. Life threatening congenital anomalies
  4. Congenital skin anomalies
  5. Hydrops Fetalis
  6. Congenital infection of the skin
  7. History of any previous treatment with the ointment
  8. Newborns admitted for major surgical procedure with expected high rates of infectious complications.
  9. Newborns with positive baseline blood cultures
  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: NCT01396642

Locations
Pakistan
The Aga Khan University
Karachi, Sindh, Pakistan
The Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
Principal Investigator: Zulfiqar ZB Bhutta, MBBS, PhD The Aga Khan University
Principal Investigator: Rehana A Salam, MSc The Aga Khan University
  More Information

No publications provided

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT01396642     History of Changes
Other Study ID Numbers: 1258-CHS/ERC-09
Study First Received: July 7, 2011
Last Updated: August 1, 2012
Health Authority: Pakistan: The Aga Khan University

Keywords provided by Aga Khan University:
Topical Emollient Therapy
Emollient
Preterm
Hospital Acquired Infection

Additional relevant MeSH terms:
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014