Clinical trial NCT01396642: Topical Emollient Therapy
Official title: Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Stream Infection
Keywords: Topical Emollient Therapy
Emollient
Preterm
Hospital Acquired Infection
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 258
Sex: ALL
Minimum age (years): 5
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Hospital Acquired Blood Stream Infection
timeFrame: 28 days of life
Secondary outcomes:
measure: Weight Gain
timeFrame: 28th Day of Life
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar ZB Bhutta, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Rehana A Salam, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salam RA, Darmstadt GL, Bhutta ZA. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F210-5. doi: 10.1136/archdischild-2014-307157. Epub 2015 Jan 30.