|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00910234 |
|
Date of registration:
|
28/05/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants
|
|
Scientific title:
|
Early Treatment With Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants: Comparison of High and Low Dose |
|
Date of first enrolment:
|
August 2009 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00910234 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
Taiwan
| | | | | | | |
|
Contacts
|
|
Name:
|
Hsiang-Yu Lin, MD |
|
Address:
|
|
|
Telephone:
|
886-4-22052121 |
|
Email:
|
hsyulin@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Bai-Horng Su, MD, PhD |
|
Address:
|
|
|
Telephone:
|
886-4-22052121 |
|
Email:
|
bais@ms49.hinet.net |
|
Affiliation:
|
|
|
|
Name:
|
Bai-Horng Su, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
China Medical University Hospital, Taiwan |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- After informed consent is obtained, very preterm infants with gestational age of <
32 weeks and admit to our NICU are eligible for enrollment.
Exclusion Criteria:
- Genetically defined syndromes,
- Congenital malformations that adversely affect neurodevelopment.
Age minimum:
N/A
Age maximum:
6 Hours
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Infant, Premature
|
|
Intraventricular Hemorrhage
|
|
Leukomalacia, Periventricular
|
|
Retinopathy of Prematurity
|
|
Intervention(s)
|
|
Drug: Normal saline
|
|
Drug: recombinant human erythropoietin (rhEpo)
|
|
Primary Outcome(s)
|
|
The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP.
[Time Frame: 2 months]
|
|
Secondary Outcome(s)
|
|
The secondary outcomes are sepsis, necrotizing enterocolitis (NEC), persistent ductus arteriosus (PDA), apnea of prematurity, and chronic lung disease.
[Time Frame: 2 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|