A pilot study to inform a randomised controlled trial of iodine supplementation in preterm infants - iodine rct

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002404-42-GB

Enrollment

Registered

2005-06-15

Start date

2005-08-18

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

transient hypothyroxinaemia

Interventions

Product Name: Aqueous Iodine Oral Solution Product Code: non-proprietary Pharmaceutical Form: Oral solution INN or Proposed INN: Iodine, Potassium Iodide Other descriptive name: Diluted Lugol's Iodine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: infants born ==65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Infants born over 30 weeks gestation. Mothers and infants will be excluded from the study if they are known to be viral hepatitis/HIV positive, have problems giving consent because of mental illness or communication difficulties. Infants with serious congenital anomaly will be excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 ;Secondary Objective: none;Primary end point(s): iodine balance at postnatal days 7, 14, 28	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026