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Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants

Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants - Randomized controlled trial for the prevention of respiratory deterioration due to silent aspiration by transpyloric tube feeding in extremely low birth weight infants

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001728
Enrollment
40
Registered
2009-03-01
Start date
2001-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Low Birth Weight Infants

Interventions

transpyloric tube feeding group gastric tube feeding group

Sponsors

Osaka Medical Center and Research Institute for Maternal and Child Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: birth weight less than 1000g less than 28 weeks gestation mechanical ventilation had been performed enteral feeding had been reached 50ml/kg/day parental consent

Exclusion criteria

Exclusion criteria: intestinal disorder including necrotizing enterocolitis congenital anomalies such as chromosomal anomalies congenital heart diseases hydrops

Design outcomes

Primary

MeasureTime frame
Chronic lung disease, additional oxygen requirement at 36weeks post conceptional age failure criteria,respiratory deterioration and intestinal disorder

Secondary

MeasureTime frame
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

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026