To confirm the previously reported negative predictive value of urine NTproBNP for ROP in large, multi center cohort of preterm infants.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
100% negative predictive cut-off values for urinary NTproBNP concentrations
normalized to creatinine at 2 and 4 weeks of life for threshold ROP (stage II+
or more in zone 2 or 3, or any ROP in zone 1)
Secondary outcome
100% negative predictive cut-off values for urinary NTproBNP concentrations
normalized to creatinine at 2 and 4 weeks of life for ROP intervention
(laser-/cryo surgery )
100% negative predictive cut-off values for urinary NTproBNP concentrations at
2 and 4 weeks of life without normalization to creatinine for threshold ROP
(stage II+ or more in zone 2 or 3, or any ROP in zone 1)
100% negative predictive cut-off values for urinary NTproBNP concentrations at
2 and 4 weeks of life without normalization to creatinine for ROP intervention
(laser/cryo surgery)
Background summary
Preterm infants with a gestational age < 30 weeks and a birth weight < 1500 g
have an increased risk of retinopathy of prematurity (ROP). For this reason the
eyes of these infants are screened every 2 weeks by the ophthalmologist, a
procedure that can be uncomfortable and painful. In the end, only 10% of the
infants have ROP that needs treatment. A recent study showed that NTproBNP
measured in urine spots a 2 and 4 weeks of age, has a excellent negative
predicting value for ROP. Using NTproBNP might significantly reduce the need
for eye exams in preterm infants.
Study objective
To confirm the previously reported negative predictive value of urine NTproBNP
for ROP in large, multi center cohort of preterm infants.
Study design
In this observational study NTproBNP will be determined in urine spots at 2 and
4 weeks of age. Care of the preterm infants will be according to the local
protocol and the NTproBNP results will have no impact on treatment or eye
screening. By combining the results from the eye exams and the NTproBNP,
diagnostic value of the later will be determined.
Study burden and risks
This is an observational study in which infants will receive care as usual.
Urine will be collected at 2 and 4 weeks via a small plastic bag or a cotton
wool. Based on this design there is no anticipated burden or risk for the
patients participating in this study.
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Gestational age < 30 weeks and birth weight < 1500 gram
Exclusion criteria
- Lack of parental consent
- infant likely to die soon
- infant scheduled for early transfer to another institution without reliable ophthalmologic examinations (not applicable to the Netherlands)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40854.018.12 |