Comparison of two machines that help babies with breathing difficulties

Not Applicable

• Conditions: Health Condition 1: J00-J99- Diseases of the respiratory systemHealth Condition 2: null- Newborn infants with neonatal respiratory distress syndrome

• Registration Number: CTRI/2017/05/008581
• Lead Sponsor: Medical Technology Transfer and Services Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

IN-1 Infants born at the hospital (â??inborn infantsâ??)

IN-2 Infants with a gestational age at birth (weeks +days) in the range >= 28+0 to <= 36+6;

IN-3 Infants thought to have RDS (clinically diagnosed after onset of respiratory distress <6 hours of age, sometimes confirmed by X-ray showing homogenous bilateral opacity) who would routinely be provided CPAP; and

IN-4 Infants <24 hours old at the time of fulfilling other inclusion criteria.

Exclusion Criteria

EX-1 Infants with a 1-minute Apgar score <3 (as a marker of severe birth asphyxia);

EX-2 Infants who received MV prior to randomisation;

EX-3 Infants with suspected meconium aspiration syndrome will be excluded to avoid any imbalance in this condition across groups;

EX-4 Infants clinically suspected to have another specified serious condition as their main disease process, diagnosed prior to randomisation, specifically: cardiac anomaly, other congenital malformation with respiratory sequelae, septicaemia, pulmonary haemorrhage, pneumothorax, meningitis, poor respiratory effort or recurrent apnoea, or brain haemorrhage (IVH Grades III or IV);

EX-5 Infants who have an airway abnormality precluding the use of the standard CPAP interface proposed for this study (e.g., Pierre-Robin sequence, cleft lip or cleft palate) or who have a neuromuscular condition that interferes with respiration;

EX-6 Infants whose treating clinician believes should not be randomised due to some other condition, or for any other reason (reason to be documented).

Study & Design

• Study Type: Interventional
• Study Design: Not specified