MedPath

Randomised controlled trial to see if Continuous Positive Airways Pressure will reduce the number of infants transferred from Special Care Nurseries to Intensive care Nurseries.

Phase 1
Active, not recruiting
Conditions
Babies born with respiratory distress in non-tertiary centres.
Reproductive Health and Childbirth - Complications of newborn
Respiratory - Other respiratory disorders / diseases
Registration Number
ACTRN12606000264583
Lead Sponsor
Adam Buckmaster
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
300
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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