A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants.

A pilot study to assess the efficacy and safety of Heliox inhalation therapy for resuscitation to preterm infants. - Heliox inhalation therapy for preterm infants

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015061

Enrollment

Registered

2014-09-04

Start date

2013-06-18

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

preterm infants

Interventions

According to NRP(neonatal resuscitation program) protocol, subjects are treated with not standard air but heliox. in one year before same study period, infants who meet the inclusion criteria.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Infants who is born at Nagano Children's hospital (2) Infants between 30 and 36 weeks of gestational age (3) Infants requiring mask PEEP or Bag mask bagging according to NRP(neonatal resuscitation program) protocol (4) written informed consents were obtained from their parents

Exclusion criteria

Exclusion criteria: (1) infants who was suspected severe congenital heart disease before birth (2) infants who was suspected chromosomal abnormality before birth (3) infants who was suspected multiple malformation before birth (4) infants who was suspected severe surgical disease before birth (5)

Design outcomes

Primary

Measure	Time frame
intubation rate within the first 7 days after birth	—

Secondary

Measure	Time frame
efficacy(duration of ventilator support,CPAP, and oxygen inhalation, length of NICU stay) safety(mortality, incidence of adverse ivents)	—

Countries

Japan

Contacts

Public ContactArata Oda

Nagano Children's Hospital Division of Neonatology

araoda@gmail.com0263-73-6700

Outcome results

None listed

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