UMIN ID: UMIN000001728
Registered date:01/03/2009
Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Extremely Low Birth Weight Infants |
| Date of first enrollment | 2001/06/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | transpyloric tube feeding group gastric tube feeding group |
Outcome(s)
| Primary Outcome | Chronic lung disease, additional oxygen requirement at 36weeks post conceptional age failure criteria,respiratory deterioration and intestinal disorder |
|---|---|
| Secondary Outcome | Chronic lung disease, additional oxygen requirement at 28day of life Mean Airway Pressure on ventilator FiO2 FSp95,FiO2 to keep SpO2>95% at rest RAS,Room Air Saturation Growth and Development |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 0weeks-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | intestinal disorder including necrotizing enterocolitis congenital anomalies such as chromosomal anomalies congenital heart diseases hydrops |
Related Information
| Primary Sponsor | Osaka Medical Center and Research Institute for Maternal and Child Health |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| s-tanaka@bca.bai.ne.jp | |
| Affiliation | Osaka Medical Center and Research Institute for Maternal and Child Health Departments of Neonatology |
| scientific contact | |
| Name | Shinya Tanaka |
| Address | 840 Murodou-cho, Izumi-city, Osaka, Japan Japan |
| Telephone | |
| Affiliation | Osaka Medical Center and Research Institute for Maternal and Child Health Departments of Neonatology |