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出境医 / 临床实验 / Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis

Study Description
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.

Condition or disease Intervention/treatment Phase
Premature Infant Drug: EPO Drug: Normal saline Phase 2

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
Actual Study Start Date : January 2014
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Erythropoietin
Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth.
 Drug: EPO
Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
Other Name: Epoetin Beta
Placebo Comparator: Normal saline
Infants in the control group are given normal saline intravenously with the same volume as EPO every other day for 2 weeks.
 Drug: Normal saline
Infants in control group are administered normal saline with the same volume and period as EPO.
Outcome Measures
Primary Outcome Measures :
  1. Incidence of NEC [ Time Frame: 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 Outcome Measures :
  1. Incidence of low height in patients with NEC [ Time Frame: 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.

  2. Incidence of low weight in patients with NEC [ Time Frame: 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.

  3. Incidence of low head circumference in patients with NEC [ Time Frame: 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.

  4. Incidence of MDI<70 in patients with NEC [ Time Frame: 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.

  5. Incidence of cerebral palsy in patients with NEC [ Time Frame: 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.

  6. Incidence of blindness in patients with NEC [ Time Frame: 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.

  7. Incidence of deafness in patients with NEC [ Time Frame: 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.

  8. The effect of EPO treatment on blood messenger RNA (mRNA) expression [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
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China, Henan
Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Zhengzhou Children's Hospital, China
The First Affiliated Hospital of Zhengzhou University
Women and Children Health Care Center of Luoyang, China
Göteborg University
Investigators
Layout table for investigator information
Study Chair: Changlian Zhu, PhD Third Affiliated Hospital of Zhengzhou University
Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		Incidence of NEC [ Time Frame: At 36 weeks of corrected age ]
To compare the incidence of NEC between EPO group and control group at 36 weeks of corrected age
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • Incidence of low height in patients with NEC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Incidence of low height in patients with NEC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 pantients with NEC [ Time Frame: 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 pantients with NEC [ Time Frame: 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 pantients with NEC [ Time Frame: 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 pantients with NEC [ Time Frame: 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 mRNA expression [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
Official Title  ICMJE Erythropoietin Protects Very Preterm Infants Against Necrotizing Enterocolitis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Premature Infant
Intervention  ICMJE
  • Drug: EPO
    Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
    Other Name: Epoetin Beta
  • Drug: Normal saline
    Infants in control group are administered normal saline with the same volume and period as EPO.
Study Arms  ICMJE
  • Experimental: Erythropoietin
    Infants in the EPO group are given EPO 500IU/kg dissolved in 2 ml saline intravenously every other day for 2 weeks starting within 72 hours after birth.
    Intervention: Drug: EPO
  • Placebo Comparator: Normal saline
    Infants in the control group are given normal saline intravenously with the same volume as EPO every other day for 2 weeks.
    Intervention: Drug: Normal saline
Publications *
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019) 		1285
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2019
Actual Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 72 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919500
Other Study ID Numbers  ICMJE HN-2014002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access requests will be assessed by sponsor. Requestors will be required to sign a Data Access Agreement.
Responsible Party Changlian Zhu, Zhengzhou University
Study Sponsor  ICMJE Zhengzhou University
Collaborators  ICMJE
  • Zhengzhou Children's Hospital, China
  • The First Affiliated Hospital of Zhengzhou University
  • Women and Children Health Care Center of Luoyang, China
  • Göteborg University
Investigators  ICMJE
Study Chair: Changlian Zhu, PhD Third Affiliated Hospital of Zhengzhou University
PRS Account Zhengzhou University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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