Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates

Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates at Cipto Mangunkusumo Hospital

The aim of the study is to compare the non-inferiority of the Mix-safe T-piece resuscitator (intervention group) to the Neopuff T-piece resuscitator (control group) in providing respiratory assistance during the resuscitation of newborns. If Mix-safe is proven to be non-inferior, the study intends to support its distribution to healthcare facilities that handle delivery and neonatal resuscitation.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn; Neonatal Respiratory Disorders
• Intervention / Treatment: Device: Mixsafe T piece resucitator; Device: Standardized T Piece resuscitator

Detailed Description

Delivery and the transition from intrauterine to extrauterine life involve the respiratory transition from the placenta to the lungs. Most neonates breathe spontaneously at birth, but 10% require stimulation, and 1% need positive pressure ventilation. Respiratory disturbances in newborns require proper management because they contribute to high morbidity and mortality rates. The T-piece resuscitator is a commonly used modality for respiratory support. Mix-safe® (Fyrom) is a T-piece resuscitator with an internal compressor developed in Indonesia, offering cost-effective and precise oxygen mixing without the need for compressed air. As of now, there have been no studies examining the non-inferiority status of Mix-safe compared to standard TPR. If proven non-inferior, this device should be distributed across healthcare facilities handling delivery and neonatal resuscitation.

This research is a randomized controlled trial, a non-inferiority trial comparing Mix-safe® (treatment group) with NeopuffTM (control group) in providing respiratory assistance during the resuscitation process of newborns. The study is conducted in the Perinatology unit of Cipto Mangunkusumo National Hospital.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • RSUPN Cipto Mangunkusumo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Neonates who require respiratory assistance, either VTP or CPAP, according to the IDAI 2022 neonatal resuscitation guidelines.
• Parents/guardians agree to participate in the study.

Exclusion Criteria:

• Neonates with congenital malformations that interfere with respiration: cleft lip and palate, choanal atresia, Pierre-Robin syndrome, cystic hygroma, facial region tumors, congenital diaphragmatic hernia.
• Neonates with congenital metabolic disorders.
• Neonates suspected of having a syndrome or genetic disorder.
• Neonates with pulmonary hypoplasia.
• Gestational age < 25 weeks.
• Birth weight < 500 g.
• Known to have congenital heart defects through fetomaternal ultrasound examination.
• Parents/guardians do not agree to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mixsafe; Mix-safe® (Fyrom) connected to an oxygen source with a maximum total mixed flow of 8 L/minute and Fyrom humidifier.	Device: Mixsafe T piece resucitator; Compressor based T piece resuscitator
Active Comparator: Control Group; Neonatal resuscitation using standardized T Piece Resuscitator	Device: Standardized T Piece resuscitator; Standardized T piece resuscitator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation at five minute of life	Oxygen saturation (in percentage)	from birth until the 5th minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve peripheral oxygen saturation at 80%	Time to achieve peripheral oxygen saturation at 80%	from birth until oxygen saturation at 80% or until 10 minutes of life, whichever comes first
Heart rate at five minutes of life	Heart rate at five minutes of life	From birth until five minutes of life
Oxygen fraction at five minutes of life	Oxygen fraction at five minutes of life	From birth until five minutes of life.
Time to achieve HR > 100x/min	Time to achieve heart rate more than 100 beat per minute.	From birth until 10 minutes of life
Maximum FiO2	Maximum oxygen fraction during resuscitation	From birth until 10 minutes of life.
APGAR at five minutes	APGAR score at five minutes of life.	From birth until five minutes of life
Duration of CPAP	Duration of CPAP used in the delivery room, measured in minutes	From birth until ten minutes of life
Duration of PPV	Duration of PPV used in the delivery room, measured in minutes	From birth until ten minutes of life
Intubation	Intubation at delivery room	From birth until ten minutes of life
Need for surfactant	Administration of surfactant during hospitalization	From birth until discharged or death, whichever comes first, maximum followed up to 120 days.
Need for methylxanthine	Administration of methylxanthine during hospitalization	From birth until discharged or death, whichever comes first, followed up to 120 days
Length of stay	Duration of hospitalization among surviving patients	From birth until dishcarged or followed up to 120 days, whichever comes first
Intraventricular Hemorrhage	Bleeding into the brain's ventricular system in preterm infants, graded I-IV by severity on cranial ultrasound or neuroimaging.	From birth until death or discharged, whichever comes first, followed up to 120 days
Periventricular Leukomalacia	White matter brain injury near the ventricles due to ischemia or inflammation, associated with later neurodevelopmental impairment. Grading from I to IV on USG or neuroimaging.	From birth until death, discharged, whichever comes first, followed up to 120 days
Retinopathy of Prematurity	Abnormal retinal vascular development in preterm infants that may progress to retinal detachment and visual impairment if severe. Grade I to IV	From birth until death or discharged, whichever comes first, followed up to 120 days.

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital
• Investigators: Principal Investigator: Rinawati Rohsiswatmo, Prof., M.D., Ph.D., Dr Cipto Mangunkusumo Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Actual): February 6, 2025
• Study Completion (Actual): April 21, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: MIXSAFE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As written in the informed consent that no individual data of participant will be made public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No