ACTRN12606000264583
Active, not recruiting
Phase 1
Randomised controlled trial of headbox oxygen versus Continuous Positive Airways Pressure (CPAP) to reduce up-transfer of infants with respiratory distress in non-teritary hospitals.
Adam Buckmaster0 sites300 target enrollmentJanuary 8, 2003
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Babies born with respiratory distress in non-tertiary centres.
- Sponsor
- Adam Buckmaster
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. dagnosed with respiratory distress. Defined as al least one of the following: recession, grunt, nasal flare, or tachypnoea (respiratory rate \>60/minute)2\. Who require \>30% oxygen to maintain SaO2 or\> or \= 94% over a period of \>30minutes.3\. Babies aged less than 24 hours
Exclusion Criteria
- •1\. Infants \< 31wks gestation. 2\. Infants \<1200 grams. Corresponds to the 10th percentile for 31 weeks gestation. 3\. Apgar score \= 3 at 5minutes of age. Used as an arbitrary and de\-facto indicator of possible perinatal asphyxia.4\. Cardiac cause of respiratory distress. 5\. Any infant who is perceived by their paediatrician to need NICU care. This out clause” will provide an added safety mechanism and will cover infants with, for example, congenital anomalies. Potential implications for generalisability will be assessed by recording non\-identifying details of all infants excluded for this reason, along with the reason for transfer.
Outcomes
Primary Outcomes
Not specified
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