A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings. SAVE Preterm trial, Saving preterm infants by Adopting Vital Equipment.

A preterm infant life-saving package including a simple and affordable incubator and a portable flow generator mask-CPAP in resource-limited settings. SAVE Preterm trial, Saving preterm infants by Adopting Vital Equipment. - SAVE Preterm trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053350

Enrollment

350

Registered

2024-01-16

Start date

2024-02-01

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

Preterm birth complications

Interventions

Body temperature management with a simple and affordable incubator and respiratory support with a portable flow generator mask-CPAP.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants who birth weight are from 1,200 to 1,799g with respiratory failure.

Exclusion criteria

Exclusion criteria: Neonates with congenital malformations.

Design outcomes

Primary

Measure	Time frame
The primary outcome is survival to hospital discharge. In the research area, patients may be discharged to home care if high mortality is anticipated. Such discharges are also included in the category of survival discharge.	—

Secondary

Measure	Time frame
The secondary outcome is in-hospital mortality within 28 days of birth including death confirmed through telephone follow-up post-discharge.	—

Countries

Asia(except Japan),Africa

Contacts

Public ContactEiji Hirakawa

Kagoshima City Hospital Department of Neonatology

hirakawaeiji@gmail.com0990-230-7000

Outcome results

None listed

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