High humidity decreases symptomatic patent ductus arteriosus

JRCT ID: jRCT1032190068

Registered date:05/08/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: extremely premature infant, patent ductus arteriosus
• Date of first enrollment: 01/08/2019
• Target sample size: 30
• Study type: Interventional
• Intervention(s): High humidity care will be started within 6 hours after admission. Humidity inside the incubator will be kept at 90% until 72 hours after birth. After that, the humidity will be decreased 5% per day to 60% within 6 days after starting to decrease the humidity.

Outcome(s)

• Primary Outcome: The incidence of symptomatic patent ductus arteriosus within 7 days from birth

Secondary Outcome

Total amount of indomethacin administered until 14 days after birth.
Maximum ascent rate of serum sodium concentration until 7 days after birth or until the onset of the symptomatic patent ductus arteriosus.
The incidence of hypernatremia (Na > 145mEq/L) until 7 days after birth.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 1age old
• Gender: Both
• Include criteria: Preterm infants at gestational weeks of 24 to 27 who admitted to neonatal intensive care unit at Yokohama city university medical center

Exclude criteria

congenital abnormality
severe asphyxia (APGAR score 4 points or less at 5 minutes)
twin to twin transfusion syndrome apparent at birth
birth at another hospital
birth from underage and unmarried mother

Related Information

• Primary Sponsor: Hirata Michisato