Abstract
BackgroundNecrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.MethodsThe study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.ResultsA total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).ConclusionRepeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants.Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500
Highlights
Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC
Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models [9,10,11], and a retrospective analysis showed that recombinant human EPO (rhEPO) (200 IU/ kg intravenously with continuous infusion for 2 weeks starting on the first day of life, or 400 IU/kg subcutaneously three times a week) protected against NEC in very low birth weight infants [12]
RhEPO treatment decreased the incidence of NEC in very preterm infants A total of 51 infants (3.8%) of the 1285 very preterm infants developed confirmed NEC (Stage II and III). rhEPO treatment reduced the incidence of NEC (17.1% vs. 12.0%, p = 0.010) and confirmed
Summary
Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models [9,10,11], and a retrospective analysis showed that rhEPO (200 IU/ kg intravenously with continuous infusion for 2 weeks starting on the first day of life, or 400 IU/kg subcutaneously three times a week) protected against NEC in very low birth weight infants [12]. Our previous randomized controlled trial showed that repeated-dose rhEPO (500 IU/kg every other day for 2 weeks starting within 72 h after birth) promoted good long-term neurological outcomes in very preterm infants and showed a protective tendency against NEC [18], but the total number of patients was not enough for accurately evaluating the effect of rhEPO against NEC. The aim of this study was to further investigate the effect of repeated low-dose rhEPO on NEC in very preterm infants
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