Infant Flow bi-level nasal positive airway pressure (BiPAP) vs. Infant Flow nasal continuous positive airway pressure (CPAP) in preterm infants less than 1500g with respiratory distress syndrome following INSURE treatment: a multicenter randomised controlled trial(RCT)

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-ICR-15005879
• Date of registration: 2015-01-24
• Prospective Registration: Yes
• Primary sponsor: Department of Neonatology, Tongji Hospital, Huazhong University of Science and Technology
• Public title: Infant Flow bi-level nasal positive airway pressure (BiPAP) vs. Infant Flow nasal continuous positive airway pressure (CPAP) in preterm infants less than 1500g with respiratory distress syndrome following INSURE treatment: a multicenter randomised controlled trial(RCT)
• Scientific title: Infant Flow bi-level nasal positive airway pressure (BiPAP) vs. Infant Flow nasal continuous positive airway pressure (CPAP) in preterm infants less than 1500g with respiratory distress syndrome following INSURE treatment: a multicenter randomised controlled trial(RCT)
• Date of first enrolment: 2015-02-01
• Target sample size: 1:130;2:130;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=10326
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Rong Zhihui
• Affiliation: Department of Neonatology, Tongji Hospital, Huazhong University of Science and Technology

• Name: Rong Zhihui

Key inclusion & exclusion criteria

Inclusion criteria: Infants of birth weight less than 1500g, inborn, affected by RDS following INSURE treatment, were considered eligible in Tongji Hospital and Xiangyang Central Hospital. RDS was diagnosed within four hour of life on radiological and clinical criteria. The RDS diagnosis was based on the classic symptoms such as the need for oxygen supplement, tachypnea, retraction and grunting. RDS was confirmed by typical radiological pattern with decreased lung expansion with reticulogranular pattern and air bronchograms.
Exclusion criteria: Infants with lethal congenital anomalies, congenital abnormalities of the upper airway tract were excluded.

Age minimum: 0
Age maximum: 0
Gender: Both

Health Condition(s) or Problem(s) studied

bronchopulmonary dysplasia

Intervention(s)

1:SiPAP;2:CPAP;

Primary Outcome(s)

BPD;sustained extubation for 7 days;physical growth, lung function and the neurological examination results at 2 years of age;

Source(s) of Monetary Support

Canada-China Clinical Research Program MOH Key Laboratory of Neonatal Diseases, Children's Hospital of Fudan University, 399 Wanyuan Road, Shanghai