Retinopathy of prematurity (ROP) Eye Diseases Retinopathy of prematurity
Conditions
Interventions
Infants at each unit were grouped in blocks:
1. 1st block: gestational age 29+0 weeks)
Infants were randomly assigned to a treatment group using the sealed envelope technique which were prepared at
Sponsors
University of Florence (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants with gestational age < 32 weeks after parental informed consent
Exclusion criteria
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)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Gestational and post-natal age at ROP diagnosis 2. The need for surgical treatment (laser- or cryo-therapy) 3. The incidence of sepsis, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and mortality | — |
Primary
| Measure | Time frame |
|---|---|
| 1. The successful rate of lutein and zeaxanthin supplementation at preventing ROP 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 | — |
Countries
Italy
Outcome results
None listed