Clinical trial NCT03919500: Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
Official title: Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature Infant
Keywords: Preterm infant
Necrotizing enterocolitis
Erythropoietin
Neurodevelopment
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Zhengzhou Children's Hospital, China
name: The First Affiliated Hospital of Zhengzhou University
name: Women and Children Health Care Center of Luoyang, China
name: Göteborg University
First posted: 2019-04-18
Enrollment: 1285
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of repeated low-dose erythropoietin (EPO) treatment on necrotizing enterocolitis (NEC) in very preterm infants. Half of participants will receive EPO, while the other half will receive a placebo.

Detailed description: NEC is one of the most severe complications in preterm neonates and is associated with high morbility and mortality. Studies have reported that EPO treatment decreases the incidence and severity of experimental NEC in animal models. Evidence from previous clinical studies about the effect of EPO treatment against NEC have all been hampered by small numbers of patients. The study is to investigate whether repeated low-dose EPO protects against NEC. Preterm infants with gestational age ≤32 weeks who are admitted to neonatal intensive care units within 72 hours after birth are randomized to EPO (500IU/kg, intravenously every other day for 2 weeks) or control group (the same volume of saline). Primary outcome is the incidence of NEC at 36 weeks of corrected age. Secondary outcome is growth and neurodevelopment at 18 months of corrected age in infants with NEC.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with gestation age ≤ 32weeks
* Within 72 hours after birth
* Written informed consent obtained from parents

Exclusion Criteria:

* Genetic or metabolic diseases
* Congenital abnormalities
* Polycythemia
* Intracranial hemorrhage grade III/IV
* Unstable vital signs (such as respiration and circulation failure)

Primary outcomes:
measure: Incidence of NEC
timeFrame: At 36 weeks of corrected age
Secondary outcomes:
measure: Incidence of low height in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of low weight in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of low head circumference in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of MDI<70 in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of cerebral palsy in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of blindness in patients with NEC
timeFrame: At corrected age of 18 months
measure: Incidence of deafness in patients with NEC
timeFrame: At corrected age of 18 months
measure: The effect of EPO treatment on blood messenger RNA (mRNA) expression
timeFrame: At 3 weeks after birth
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Third Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Third Affiliated Hospital of Zhengzhou University
name: Changlian Zhu, PhD
role: STUDY_CHAIR
References:
citation: Sun H, Song J, Kang W, Wang Y, Sun X, Zhou C, Xiong H, Xu F, Li M, Zhang X, Yu Z, Peng X, Li B, Xu Y, Xing S, Wang X, Zhu C. Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants. J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.
citation: Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, Yuan X, Zhang S, Ding X, Zhang Y, Kang W, Qian L, Zhou W, Wang X, Cheng X, Zhu C. Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial. J Transl Med. 2020 Aug 8;18(1):308. doi: 10.1186/s12967-020-02459-w.