Can MINAR, a locally made infant warming bed safely support newborn resuscitation compared with the standard device used in hospitals?

A randomized non-inferiority study comparing the MINAR™ infant warmer resuscitator with the Dräger Resuscitaire® for clinical feasibility and safety outcomes in neonates requiring delivery room resuscitation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88734666

Enrollment

Registered

2026-01-14

Start date

2025-08-04

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Neonates requiring delivery room resuscitation or stabilization due to respiratory compromise, including apnea, bradycardia, respiratory distress, or persistent cyanosis, necessitating oxygen supplementation and/or ventilatory support. Pregnancy and Childbirth

Interventions

This study is conducted as an interventional, two-arm, parallel-group clinical feasibility study comparing the MINAR™ Infant Warmer Resuscitator with the Dräger Resuscitaire® as the comparator device.

Eligibility

Sex/Gender

All

Age

0 Days to 27 Days

Inclusion criteria

Inclusion criteria: 1. Live-born neonates, delivered by vaginal delivery or caesarean section, who required resuscitation or stabilization following completion of initial steps of neonatal resuscitation. 2. Requirement for oxygen supplementation and/or ventilatory support, defined by one or more of the following criteria in accordance with NRP and WHO guidelines: 2.1. Apnea or gasping respiration 2.2. Heart rate <100 beats per minute after initial steps 2.3. Clinical signs of respiratory distress (e.g., nasal flaring, chest retractions, grunting) 2.4. Persistent central cyanosis despite initial airway positioning and stimulation 3. Neonates managed using an infant warmer resuscitator bed during delivery room or immediate postnatal stabilization. 4. Informed consent obtained from parents or legal guardians.

Exclusion criteria

Exclusion criteria: Not meeting key inclusion criteria

Countries

Indonesia

Contacts

Public ContactReza Widianto;Jenifer Kiem Sudjud;Aviani

;

reza.widianto.sudjud@unpad.ac.id;jenifer_kiem@yahoo.co.id+6281320003010;+6285794495885

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026