Continuous positive airway pressure (CPAP) weaning trial

A continuous positive airway pressure (CPAP) weaning trial to determine the most efficient method in weaning babies less than 30 weeks gestational age "OFF" CPAP.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12606000155594

Enrollment

200

Registered

2006-05-03

Start date

2006-03-20

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 small babies <30 weeks gestational age have a very immature respiratory system and require respiratory support for a limited period of time until they mature and can breath by themselves. Continuous positive airway pressure (CPAP) is one such method by which support can be given to these immature babies to allow them to breath without being put on a ventilator or breathing machine. When these babies have matured a little the CPAP is weaned in order to allow the babies to breath without support. This trial will look at 3 methods of weaning CPAP to see which method is most efficient in allowing the babies to breath on their own. The trial has started at Westmead Hospital and we hope to include other Hospitals to increase our numbers in the trial.

Interventions

This trial will look at 3 methods of weaning CPAP. Method 1. When the baby has reached the stability criteria they will be taken OFF CPAP. Method 2. When the baby has reached the stability criteria they will be gradually taken OFF CPAP from 30 minutes to completely OFF . Method 3. When the baby has reached the stability criteria they will be gradually taken OFF CPAP from 30 minutes to completely OFF as in method 2, but when the baby is having time OFF CPAP they will have supplemental air or ox

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to 30 Weeks

Healthy volunteers

Inclusion criteria

1.All babies <30 weeks gestational age 2.On CPAP for >24 hours 3.Babies either extubated to CPAP or as a primary treatment for respiratory distress Criteria for commencing weaning: Babies must have all of the following for the past 12 hours:- 1.CPAP <6 cm H2O 2.Oxygen requirement less than 26% and not increasing 3.RR less than 60 4.No significant chest recession 5.Less than 3 episodes of mild self reverting apnoeas and/or bradycardias and/or desaturations in 1 hour for the previous 6 hours 6.Average saturation above 87% most of the time and/or transcutaneous (TcPO2)/arterial PaO2 >50 mm Hg. 7.Tolerates nose rests well during nursing cares 8.Not treated for patent ductus arteriosus (PDA) or sepsis Criteria for failed trial “OFF” at least 2 of the following:- 1.Increase work of breathing (Intercostal recession and accessory muscles contributing for respiration) with RR >75 for >1 hour 2.Increased apnoeas and/or bradycardias and/or desaturations >2 in previous 1 hour 3.Major apnoea or bradycardia requiring more sustained stimulation/ resuscitation 4.Increased O2 requirement >25% with average saturation <85% and/or TcPO2/PaO2 <45mmHg 5.pH of <7.2 6.PaCO2 of > 65 mmHg. The babies will be put back on CPAP if failed trial “OFF” CPAP. If a baby has a major apnoea and/or bradycardia requiring resuscitation they may require intubation and ventilation.

Exclusion criteria

1. If congenital respiratory abnormality including central and anatomical.

Outcome results