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Note: This record shows only 22 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: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-ICR-15006001
Date of registration: 2015-02-20
Prospective Registration: No
Primary sponsor: Women's Hospital, Medicine School of Zhejiang University
Public title: A pilot study of less invasive surfactant administration in very preterm infants with respiratory distress syndrome
Scientific title: Study of less invasive surfacatant adiministration in preterm infants with respiratory distress syndrome
Date of first enrolment: 2012-01-01
Target sample size: 2:80;1:80;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=10465
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Jiajun Zhu   
Address:  1 Xueshi Road, Hangzhou, Zhejiang
Telephone: +86 13858089111
Email: iamjiajunzhu@163.com
Affiliation:  Women's Hospital, Medicine School of Zhejiang University
Name: Mingyuan Wu   
Address:  1 Xueshi Road, Hangzhou, Zhejiang
Telephone: +86-571-89992033
Email: tinybaby@sina.com.cn
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: (1) infants born at 26 to 32 weeks gestational age;
(2) Infants with RDS and need PS administration with 2 hr after birth;
(3) A written informed consent for participation in the study was obtained from the parent of infants.

Exclusion criteria: (1) infants who had been previously intubated;
(2) infants with a congenital anomaly affecting respiratory function.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
respiratory distress syndrome
Intervention(s)
2:less invasive surfactant administration;1:conventional intubation;
Primary Outcome(s)
rate of mechanical ventilation in the first 72 hours;
Secondary Outcome(s)
mean duration of both MV and nCPAP and oxygen requirement;
Secondary ID(s)
Source(s) of Monetary Support
Department of Education, Zhejiang Province
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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