utein and zeaxanthin supplementation in preterm infants to prevent retinopathy of prematurity
Not Applicable
Completed
- Conditions
- Retinopathy of prematurity (ROP)Eye DiseasesRetinopathy of prematurity
- Registration Number
- ISRCTN10624844
- Lead Sponsor
- niversity of Florence (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 242
Inclusion Criteria
Infants with gestational age < 32 weeks after parental informed consent
Exclusion Criteria
1. The presence of major congenital malformation
2. Fetal hydrops
3. Death before the first ophthalmologic examination
3. Lack of lutein supplementation > 10 days during the first 30 days of life
4. Development of aggressive-posterior ROP (AP-ROP)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The successful rate of lutein and zeaxanthin supplementation at preventing ROP<br>2. The rate of primary endpoint was calculated on the basis of collected data and in agreement with those from literature, while the duration of follow up was decided on the basis of recommendation of the Italian Society of Neonatology and in agreement with the current literature
- Secondary Outcome Measures
Name Time Method 1. Gestational and post-natal age at ROP diagnosis<br>2. The need for surgical treatment (laser- or cryo-therapy)<br>3. The incidence of sepsis, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and mortality