Blood Stream InfectionNCT01396642
Topical Emollient Therapy
A study testing Topical Emollient in people with Blood Stream Infection, run by Aga Khan University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 minutes to 72 hours
- Conditions the study is for
- Blood Stream Infection
- What is being tested?
- Topical Emollient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesPakistan
- Study dates
- Jul 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 minutes to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any preterm neonates (>26 weeks and < 37 weeks of gestation by maternal dates)
- Birth weight of at least 750 gm
- Age ≤72 hours of life
- Baseline blood cultures obtained
- Expected survival > 48 hours (based on the clinical judgment by the physicians)
Who cannot join
- Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
- Neonate within first 24 hours of critical care
- Life threatening congenital anomalies
- Congenital skin anomalies
- Hydrops Fetalis
- Congenital infection of the skin
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- History of any previous treatment with the ointment
- Newborns admitted for major surgical procedure with expected high rates of infectious complications.
- Newborns with positive baseline blood cultures
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
The Aga Khan University
Karachi, Sindh, 74800
The Aga Khan University
Karachi, Sindh
About this study
Official title: Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial
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.
Read more
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.
Read the detailed description
Research question:
- 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.
- 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:
- To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates. The secondary objective is:
- To compare the weight gain among the two groups of neonates.
- Conditions
- Blood Stream Infection
- Being tested
- Topical Emollient
- Keywords
- Topical Emollient Therapy, Emollient, Preterm, Hospital Acquired Infection
- Medical subject headings
- Premature Birth, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical EmollientOther
Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
| Study group | Role | What they receive |
|---|---|---|
| Topical Emollient | Experimental | Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life Receives: Other: Topical Emollient |
| Routine Skin Care | No intervention | Neonates in this group will receive routine skin care as per unit protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Acquired Blood Stream Infection
Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission.
Measured: 28 days of life
Secondary outcomes (1)
Weight Gain
Measured: 28th Day of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Stream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar ZB Bhutta, MBBS, PhD, Principal investigator, Aga Khan UniversityRehana A Salam, MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396642
- Sponsor's protocol ID
- 1258-CHS/ERC-09
- Status last verified
- Apr 2015
- First submitted
- 7 Jul 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25637007
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Emollient Therapy on Clinical Outcomes in Preterm Neonates - A Clinical Trial
- ClinicalTrials.gov ID
- NCT01396642
- Acronym / sponsor ID
- 1258-CHS/ERC-09
- Conditions
- Blood Stream Infection
- Keywords
- Topical Emollient Therapy, Emollient, Preterm, Hospital Acquired Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- To evaluate the effectiveness of topical emollient in preventing hospital acquired infection in preterm neonates. The secondary objective is:
- To compare the weight gain among the two groups of neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Emollient | Experimental | Other: Topical EmollientNeonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life |
| Routine Skin Care | No intervention | –Neonates in this group will receive routine skin care as per unit protocol |
Who may qualify
- Ages
- 5 minutes to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any preterm neonates (>26 weeks and < 37 weeks of gestation by maternal dates)
- Birth weight of at least 750 gm
- Age ≤72 hours of life
- Baseline blood cultures obtained
- Expected survival > 48 hours (based on the clinical judgment by the physicians)
Key exclusion criteria (9 listed)
- Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
- Neonate within first 24 hours of critical care
- Life threatening congenital anomalies
- Congenital skin anomalies
- Hydrops Fetalis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical EmollientNeonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life | Other | Topical Emollient |
Primary outcome
Hospital Acquired Blood Stream Infection
Time frame: 28 days of life
Hospital Acquired Infection is defined as a blood culture positive for any organism in a neonate with baseline negative cultures on admission.
1 secondary outcome
Weight Gain
Time frame: 28th Day of Life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 25637007Salam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zulfiqar ZB Bhutta, MBBS, PhD principal investigator
Aga Khan University
Rehana A Salam, MSc principal investigator
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Emollient in people with Blood Stream Infection, run by Aga Khan University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Acquired Blood Stream Infection (time frame: 28 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.