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

NCT07422116 | Completed DMC

• 1 other identifier: MIXSAFE
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Distress Syndrome, Newborn; Neonatal Respiratory Disorders

Outcome Measures

Primary Outcomes (1)

• Oxygen saturation at five minute of life

  Oxygen saturation (in percentage)

  from birth until the 5th minutes

Secondary Outcomes (15)

• 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

  From birth until five minutes of life

• Oxygen fraction at five minutes of life

  From birth until five minutes of life.

• Time to achieve HR > 100x/min

  From birth until 10 minutes of life

• Maximum FiO2

  From birth until 10 minutes of life.

Study Arms (2)

Mixsafe

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Neonatal resuscitation using standardized T Piece Resuscitator

Device: Standardized T Piece resuscitator

Interventions

Mixsafe T piece resucitator DEVICE

Compressor based T piece resuscitator

Mixsafe

Standardized T Piece resuscitator DEVICE

Standardized T piece resuscitator

Control Group

Eligibility Criteria

• Age: 25 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rinawati Rohsiswatmo, Prof., M.D., Ph.D.

  Dr Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: February 19, 2026
• Study Start: August 15, 2024
• Primary Completion: February 6, 2025
• Study Completion: April 21, 2025
• Last Updated: February 19, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)