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.

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.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000264583

Acronym

Bubbles for Babies

Enrollment

300

Registered

2003-01-08

Start date

2002-08-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many babies are born with respiratory distress and require care in a Special Care Nursery (SCN). Whilts most of these babies get better with oxygen and other routine supports a number have to be transferred to a Neonatal Intensive Care Unit (NICU). Such a transfer has a major impact on the health of the baby and on the family unit and incurs a significant cost. Continuous Positive Airways Pressure (CPAP) is used to treat infants with respiratory distress in Australian NICUs. This proposal seeks to compare, by randomised trial, nasal CPAP to head box oxygen in SCN, as means of early treatment of respiratory distress. The study is designed to be able to detect a 50% reduction in the number of babies meeting criteria that would ordinarily result in transfer to NICUs.

Interventions

Intervention is CPAP at 5cms of water. Provided using Hudson Nasal prongs connected to an underwater seal.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 31 Weeks

Healthy volunteers

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.

Outcome results