Skin DiseasesPhase 4NCT00162747
Topical Therapy for Prevention of Infections in Preterm Infants
A Phase 4 study testing Aquaphor and Sunflower Seed Oil in people with Skin Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin. Read more about this study
- Who is it for?
- Ages 7 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Aquaphor and Sunflower Seed Oil
- How many people
- 600 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2001to Jun 2005
- Phase
- Phase 4
- 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 7 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants
Who cannot join
- Full-term infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Emollient Therapy for Prevention of Infections in Preterm Infants
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.
Read the detailed description
The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body. Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.
- Conditions
- Skin Diseases
- Being tested
- Aquaphor, Sunflower Seed Oil
- Keywords
- Pre-term infants, skin infections, infant skin, Aquaphor, sunflower seed oil, nutrition, skin care
- Medical subject headings
- Skin Diseases, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaphorDrug
Sunflower Seed OilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
Secondary outcomes (1)
Atleast four additional times over the first four weeks of the child's life, the skin will be studied by lightly rubbing the skin with a cotton swab to detect germs on the skin and observing and recording the condition of the baby's skin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startDec 2001
- Study completionJun 2005
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 Skin DiseasesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Investigators
- Gary L Darmstadt, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162747
- Sponsor's protocol ID
- 98-04-21-03-2
- Other IDs
- H990772, 914-2123
- Status last verified
- Jun 2005
- First submitted
- 7 Sep 2005
- Last updated
- 13 Sep 2005
- Results posted
- No
Publications
Darmstadt GL, Khan NZ, Rosenstock S, Muslima H, Parveen M, Mahmood W, Ahmed ASMNU, Chowdhury MAKA, Zeger S, Saha SK. Impact of emollient therapy for preterm infants in the neonatal period on child neurodevelopment in Bangladesh: an observational cohort study. J Health Popul Nutr. 2021 May 26;40(1):24. doi: 10.1186/s41043-021-00248-9.
PubMed 34039435
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Emollient Therapy for Prevention of Infections in Preterm Infants
- ClinicalTrials.gov ID
- NCT00162747
- Acronym / sponsor ID
- 98-04-21-03-2
- Conditions
- Skin Diseases
- Keywords
- Pre-term infants, skin infections, infant skin, Aquaphor, sunflower seed oil, nutrition, skin care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Jun 2005
- First posted
- 13 Sep 2005 (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.
The purpose of this study is to determine how to best take care of the skin of preterm infants in order to prevent infections through the skin.
Detailed description
The skin of babies who are born too early is not mature, which means they are at risk for infections of the skin or in the body. Their skin also become very dry, leading to cracking and breakdown, and this may feel painful or uncomfortable for the infant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants
Key exclusion criteria (1 listed)
- Full-term infant
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 |
|---|---|---|
| Aquaphor | Drug | – |
| Sunflower Seed Oil | Drug | – |
Primary outcome
Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.
1 secondary outcome
Atleast four additional times over the first four weeks of the child's life, the skin will be studied by lightly rubbing the skin with a cotton swab to detect germs on the skin and observing and recording the condition of the baby's skin.
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 13 Sep 2005.
- Derived from this study: PubMed 34039435Darmstadt GL, Khan NZ, Rosenstock S, Muslima H, Parveen M, Mahmood W, Ahmed ASMNU, Chowdhury MAKA, Zeger S, Saha SK. Impact of emollient therapy for preterm infants in the neonatal period on child neurodevelopment in Bangladesh: an observational cohort study. J Health Popul Nutr. 2021 May 26;40(1):24. doi: 10.1186/s41043-021-00248-9.
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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.
Gary L Darmstadt, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aquaphor and Sunflower Seed Oil in people with Skin Diseases, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
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 1 inclusion and 1 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 13 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Three weeks after application of the intervention, blood will be drawn from those enrolled in the control group.. 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 NCT00162747, 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 13 Sep 2005.