Premature Infant
Conditions
Keywords
Preterm infant, Necrotizing enterocolitis, Erythropoietin, Neurodevelopment
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.
Interventions
DRUGEPO
Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
DRUGNormal saline
Infants in control group are administered normal saline with the same volume and period as EPO.
Sponsors
Zhengzhou Children's Hospital, China
The First Affiliated Hospital of Zhengzhou University
Women and Children Health Care Center of Luoyang, China
Göteborg University
Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of NEC | At 36 weeks of corrected age | To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of low height in patients with NEC | At corrected age of 18 months | To compare the incidence of low height in patients with NEC between EPO and control groups via the Standardized Growth Curve for Chinese Children at 18 months of corrected age. |
| Incidence of low weight in patients with NEC | At corrected age of 18 months | To compare the incidence of low weight in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age. |
| Incidence of low head circumference in patients with NEC | At corrected age of 18 months | To compare the incidence of low head circumference in patients with NEC between EPO and control group via the Standardized Growth Curve for Chinese Children at 18 months of corrected age. |
| Incidence of MDI<70 in patients with NEC | At corrected age of 18 months | To compare the incidence of MDI\<70 in patients with NEC between EPO and control group via Bayley Scales of Infant Development (second edition) at 18 months of corrected age. |
| Incidence of cerebral palsy in patients with NEC | At corrected age of 18 months | To compare the incidence of cerebral palsy in patients with NEC between EPO and control group at 18 months of corrected age. |
| Incidence of blindness in patients with NEC | At corrected age of 18 months | To compare the incidence of blindness in patients with NEC between EPO and control group via visual acuity at 18 months of corrected age. |
| Incidence of deafness in patients with NEC | At corrected age of 18 months | To compare the incidence of deafness in patients with NEC between EPO and control group via auditory brainstem response measurement at 18 months of corrected age. |
| The effect of EPO treatment on blood messenger RNA (mRNA) expression | At 3 weeks after birth | To investigate different mRNA expression between EPO and control group, peripheral venous blood of preterm infants after EPO treatment will be collected in both EPO group and control group, and the transcriptome of the premature infant blood will be assayed by RNA sequencing. |
Countries
China
Outcome results
None listed