A pilot study to inform a randomised controlled trial of iodine supplementation in preterm infants
| ISRCTN | ISRCTN68152740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68152740 |
| EudraCT/CTIS number | 2005-002404-42 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/05/2005
- Registration date
- 19/07/2005
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert Hume
Scientific
Scientific
Division of Maternal and Child Health Sciences
University of Dundee
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A pilot study to inform a randomised controlled trial of iodine supplementation in preterm infants |
| Study acronym | Euthyroid2 |
| Study objectives | 1. We aim to determine whether enteral supplementation with iodine is effective in promoting a positive iodine balance in extreme preterm infants who are parenterally fed 2. To determine the efficacy of the oral versus the nasogastric route of iodine supplementation |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Transient hypothyroxinaemia |
| Intervention | Iodine supplementation 30 µg/kg/day versus placebo (sterile distilled water) |
| Intervention type | Supplement |
| Primary outcome measure | Serum T4 levels |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2005 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 44 |
| Key inclusion criteria | Infants who are born earlier or at 30 weeks gestation and who mothers are able to give informed consent. |
| Key exclusion criteria | Infants born over 30 weeks gestation. Infants will be excluded from the study if their mother is known to be viral hepatitis/HIV positive, or if their mother has problems giving consent because of mental illness or communication difficulties. Infants with serious congenital anomaly will be excluded. If any infant is found to have hypothyroidism, following routine Guthrie Card screening, they will be excluded from further study and treated with thyroxine. |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Dundee
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
Nethergate
Dundee
DD1 4HN
Scotland
United Kingdom
"ROR" |
https://ror.org/03h2bxq36 |
|---|
Funders
Funder type
Other
Not provided at time of registration
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2014 | Yes | No | |
| Results article | results | 01/05/2017 | Yes | No |
Editorial Notes
04/10/2018: Publication reference added.
