Should very premature babies be treated at birth with intubation and ventilation or just a continuous positive pressure into the nose?

Nasal CPAP (continuous positive airway pressure) for very preterm infants at birth: Does it reduce the incidence of chronic lung disease? A randomised controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000258550

Acronym

COIN148002 (NHMRC application number)

Enrollment

600

Registered

2001-05-02

Start date

2001-02-01

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

The standard treatment of very premature babies has been intubation and ventilation at birth. Recent non-randomised studies have shown that some of these babies can be managed with oxygen provided under a low continuous positive pressure into the nose and that this may improve some of their outcomes. This trial will be the first randomised trial to compare these two treatments and determine which has the optimal outcome for the baby.

Interventions

This project is a definitive randomised controlled trial of early CPAP in preterm infants of 25 to 28 weeks' gestation comparing CPAP at birth with intubation and ventilation at birth. 1. Nasal CPAP (continuous positive pressure) - applying oxygen under a low continuous positive pressure through the nose. 2. Intubation and ventilation - support from an infant ventilator with pressure delivered via a tube in the wind pipe (trachea).

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

25 Weeks to 28 Weeks

Healthy volunteers

Inclusion criteria

Inborn infants 25 week 0 days to 28 weeks 6 days gestation who breathe at birth & parents consent.

Exclusion criteria

Babies who have a condition which might compromise respiration. Don't breathe at birth.

Outcome results