Health Condition 1: J00-J99- Diseases of the respiratory system Health Condition 2: null- Newborn infants with neonatal respiratory distress syndrome
Conditions
Interventions
Intervention1: Dolphin CPAP: CPAP machine with oxygen intake and an on-board air compressor, and integrated blender and humidifier, delivering heated humidified blended gases through a Fisher-Paykel n
Sponsors
Medical Technology Transfer and Services Hong Kong
Eligibility
Inclusion criteria
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 IN-3 Infants thought to have RDS (clinically diagnosed after onset of respiratory distress IN-4 Infants <24 hours old at the time of fulfilling other inclusion criteria.
Exclusion criteria
Exclusion criteria: EX-1 Infants with a 1-minute Apgar score 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of inspired oxygen (FiO2), measured as a change from baselineTimepoint: 6, 12, 24, 48 and 72 hours after treatment commencement | — |
Secondary
| Measure | Time frame |
|---|---|
| A Serious adverse Event (SAEs) is any untoward medial occurrence that: Results in death; Is life-threatening (see definitional note in ClinicalTrials.gov registration); Requires inpatient hospitalisation or prolongation of existing hospitalisation; Results in persistent or significant disability/incapacity; or Is a congenital anomaly/birth defectTimepoint: From date and time of birth to date and time of hospital discharge, assessed to a maximum of 2 months of age.;Arterial blood gas analyses (pH, PaO2, PaCO2), measured as a change from baseline (where measured)Timepoint: 6, 12, 24, 48 and 72 hours after treatment commencement (where available);CPAP failure or surfactant provision (i.e., Secondary Outcomes 4 or 5)Timepoint: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.;CPAP failure: Death or need for intubation and mechanical ventilation as demonstrated by an FiO2 requirement â?¥ 60% for â?¥ 1 hour to maintain SpO2 at 90-95%Timepoint: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age;Duration of CPAP treatment (hours) in infants that do not fail CPAPTimepoint: From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.;Oxygen saturation by pulse oximetry (SpO2), measured as a change from baselineTimepoint: 6, 12, 24, 48 and 72 hours after treatment commencement;Respiratory rate (breaths/minute), measured as a change from baselineTimepoint: 6, 12, 24, 48 and 72 hours after tr | — |
Countries
India
Contacts
Public ContactDr Pradeep GCM
Ramaiah Medical College
Outcome results
None listed