The use of Aquaphor to prevent transepidermal water loss and to maintain electrolyte balance in preterm newborn infants in the first week of life.
| ISRCTN | ISRCTN89579779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89579779 |
| Secondary identifying numbers | N0060131640 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Enitan M Ogundipe
Scientific
Scientific
Neonatal Unit
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)20 8746 7881 |
|---|---|
| enitan.ogundipe@chelwest.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Will the use of an emollient (aquaphor) in the first week of life reduce transepidermal water loss (TEWL) in very preterm babies and improve their metabolic and electrolyte balance compared to infants not given the emollient treatment ? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal Diseases: Transepidermal water loss (TEWL) |
| Intervention | Standard care compared with emollient (aquaphor) therapy in addition to standard care. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | aquaphor |
| Primary outcome measure | 1. Fluid requirement in 1st week of life 2. Neonatal morbidity: electrolyte balance, metabolic balance, chronic lung disease, treated patent ductus arteriosus |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2003 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 88 babies |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2003 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Neonatal Unit
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Chelsea and Westminster Healthcare NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results | No | No |
