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High-Dose Erythropoietin in Extremely Low Gestational Age Neonates Does Not Alter Risk of Retinopathy of Prematurity
- Source :
- Neonatology
- Publication Year :
- 2020
-
Abstract
- Introduction: The Preterm Erythropoietin (Epo) Neuroprotection (PENUT) Trial sought to determine the safety and efficacy of early high-dose Epo as a potential neuroprotective treatment. We hypothesized that Epo would not increase the incidence or severity of retinopathy of prematurity (ROP). Methods: A total of 941 infants born between 24–0/7 and 27–6/7 weeks’ gestation were randomized to 1,000 U/kg Epo or placebo intravenously for 6 doses, followed by subcutaneous or sham injections of 400 U/kg Epo 3 times a week through 32 weeks post-menstrual age. In this secondary analysis of PENUT trial data, survivors were evaluated for ROP. A modified intention-to-treat approach was used to compare treatment groups. In addition, risk factors for ROP were evaluated using regression methods that account for multiples and allow for adjustment for treatment and gestational age at birth. Results: Of 845 subjects who underwent ROP examination, 503 were diagnosed with ROP with similar incidence and severity between treatment groups. Gestational age at birth, birth weight, prenatal magnesium sulfate, maternal antibiotic exposure, and presence of heart murmur at 2 weeks predicted the development of any ROP, while being on high-frequency oscillator or high-frequency jet ventilation (HFOV/HFJV) at 2 weeks predicted severe ROP. Conclusion: Early high-dose Epo followed by maintenance dosing through 32 weeks does not increase the risk of any or severe ROP in extremely low gestational age neonates. Gestational age, birth weight, maternal treatment with magnesium sulfate, antibiotic use during pregnancy, and presence of a heart murmur at 2 weeks were associated with increased risk of any ROP. Treatment with HFOV/HFJV was associated with an increased risk of severe ROP.
- Subjects :
- Male
Pediatrics
medicine.medical_specialty
congenital, hereditary, and neonatal diseases and abnormalities
Birth weight
Gestational Age
Placebo
Article
03 medical and health sciences
0302 clinical medicine
Pregnancy
Risk Factors
030225 pediatrics
Medicine
Humans
Retinopathy of Prematurity
030212 general & internal medicine
Erythropoietin
business.industry
Incidence (epidemiology)
Infant, Newborn
Gestational age
Infant
Retinopathy of prematurity
Infant, Low Birth Weight
medicine.disease
eye diseases
Pediatrics, Perinatology and Child Health
Gestation
Female
business
Infant, Premature
Developmental Biology
medicine.drug
Subjects
Details
- ISSN :
- 16617819
- Volume :
- 117
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Neonatology
- Accession number :
- edsair.doi.dedup.....e6970fe153fe5c69b5f7039be877c23e