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

ISRCTN	ISRCTN88734666
DOI	https://doi.org/10.1186/ISRCTN88734666
Sponsor	Bhakti Bersama Roartha, Ltd.
Funder	Universitas Padjadjaran

Submission date: 11/01/2026
Registration date: 14/01/2026
Last edited: 12/01/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Dr Reza Widianto Sudjud
Public, Scientific

Jl. Prof. Eyckman No.38, Pasteur
Bandung
40161
Indonesia

Phone	+6281320003010
Email	reza.widianto.sudjud@unpad.ac.id

Miss Jenifer Kiem Aviani
Public, Scientific

Jl. Prof. Eyckman No.38, Pasteur
Bandung
40161
Indonesia

Phone	+6285794495885
Email	jenifer_kiem@yahoo.co.id

Dr Lia Nazliah Abdullah
Principal investigator

Jl. Prof. Eyckman No.38, Pasteur
Bandung
40161
Indonesia

Phone	+628122379929
Email	liaabdullah@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Device feasibility
Scientific title	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
Study objectives	This study aims to assess the clinical feasibility and non-inferiority of the MINAR™ Infant Warmer Resuscitator compared with the Drӓeger Resuscitaire®, the current standard in our center, by evaluating safety, effectiveness, and key resuscitation outcomes, including APGAR score progression, Downe score–guided respiratory support, and immediate post-resuscitation parameters.
Ethics approval(s)	Approved 24/07/2025, The Research Ethics Committee of Dr. Hasan Sadikin General Hospital Bandung (Jalan Pasteur no.38, Bandung, 40161, Indonesia; +62222034953; https://web.rshs.go.id/), ref: DP.04.03/D.XIV.6.5/341/2025
Health condition(s) or problem(s) studied	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.
Intervention	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. Eligible neonates are allocated in a 1:1 ratio using a quasi-randomization method with alternating allocation, whereby participants are sequentially assigned to the MINAR or Dräger group based on their order of registration at birth. In both study arms, the assigned infant warmer resuscitator bed is prewarmed prior to use according to the manufacturer’s instructions. Immediately after birth and completion of the initial steps of neonatal resuscitation, the neonate is placed on the allocated resuscitator bed. At 5 minutes after placement, the warmer setting is adjusted to a target temperature of 36.5 °C to maintain normothermia. Oxygenation and ventilation are delivered in both groups in accordance with standard neonatal resuscitation protocols, consistent with current Neonatal Resuscitation Program (NRP) and World Health Organization (WHO) guidelines. Respiratory support, including supplemental oxygen, continuous positive airway pressure, or positive pressure ventilation, is provided as clinically indicated using the integrated resuscitation system of each device. The intervention period is 60 minutes. During this period, heart rate, respiratory rate, oxygen saturation (SpO₂), and body temperature are continuously monitored using the built-in sensors of the assigned resuscitator bed. In addition, the Downe score and APGAR score are assessed by trained clinicians at 5, 10, 15, 30, and 60 minutes following initiation of resuscitation. All interventions and assessments are performed by healthcare personnel trained in neonatal resuscitation. Standardized institutional protocols are followed to ensure patient safety, procedural consistency, and comparability between study groups.
Intervention type	Device
Phase	Phase 0
Drug / device / biological / vaccine name(s)	MINAR™ Infant Warmer Resuscitator, Dräger Resuscitaire®
Primary outcome measure(s)	Heart rate measured using a heart rate sensor at 5 , 10, 15, 30, and 60 minutes after neonates are placed on the bed Respiratory rate measured using a respiratory rate sensor at 5 , 10, 15, 30, and 60 minutes after neonates are placed on the bed Peripheral oxygen saturation measured using an SpO2 sensor at 5 , 10, 15, 30, and 60 minutes after neonates are placed on the bed Early neonatal clinical adaptation measured using the APGAR Score at 5 , 10, 15, 30, and 60 minutes after neonates are placed on the bed Severity of neonatal respiratory distress measured using the Downe Score at 5 , 10, 15, 30, and 60 minutes after neonates are placed on the bed
Key secondary outcome measure(s)
Completion date	26/10/2025

Eligibility

Participant type(s)
Age group	Neonate
Lower age limit	0 Days
Upper age limit	27 Days
Sex	All
Target sample size at registration	50
Total final enrolment	38
Key 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.
Key exclusion criteria	Not meeting key inclusion criteria
Date of first enrolment	04/08/2025
Date of final enrolment	26/10/2025

Locations

Countries of recruitment

Indonesia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			12/01/2026	No	No

Additional files

48809_MINAR Brochure.pdf: Other files

Editorial Notes

12/01/2026: Study’s existence confirmed by the Research Ethics Committee of Dr. Hasan Sadikin General Hospital Bandung, Indonesia.