Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000258550
Ethics application status
Approved
Date submitted
2/05/2001
Date registered
2/05/2001
Date last updated
2/05/2001
Type of registration
Retrospectively registered

Titles & IDs
Public title
Should very premature babies be treated at birth with intubation and ventilation or just a continuous positive pressure into the nose?
Scientific title
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.
Secondary ID [1] 27 0
Perinatal Trials Registry: PTR368
Universal Trial Number (UTN)
Trial acronym
COIN148002 (NHMRC application number)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Very premature infants 27 0
Chronic lung disease (CLD) 28 0
Condition category
Condition code
Reproductive Health and Childbirth 31 31 0 0
Childbirth and postnatal care
Respiratory 32 32 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 1098 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 58 0
Death while in neonatal unit. Reduction from 30% to 20%.
Timepoint [1] 58 0
At 36 weeks
Primary outcome [2] 59 0
Iincidence of chronic lung disease. Reduction from 30% to 20%.
Timepoint [2] 59 0
At 36 weeks
Secondary outcome [1] 87 0
1. The incidence of intubation and ventilation
Timepoint [1] 87 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [2] 88 0
2. Reasons for intubation and ventilation
Timepoint [2] 88 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [3] 89 0
3. The incidence of air leaks
Timepoint [3] 89 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [4] 90 0
4. The incidence of intracranial haemorrhages
Timepoint [4] 90 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [5] 91 0
5. Time receiving ventilation
Timepoint [5] 91 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [6] 92 0
6. Time receiving nasal CPAP
Timepoint [6] 92 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [7] 93 0
7. Time in hospital
Timepoint [7] 93 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [8] 94 0
8. Time to regain birth weight
Timepoint [8] 94 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [9] 95 0
9. Need for oxygen
Timepoint [9] 95 0
At 28 days.
Secondary outcome [10] 96 0
10. The inspired oxygen
Timepoint [10] 96 0
At 36 weeks' gestation.
Secondary outcome [11] 97 0
11. The use of concomitant methylxanthines
Timepoint [11] 97 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [12] 98 0
12. The use of postantal steroids
Timepoint [12] 98 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [13] 99 0
13. The nuber of doses of surfactant used
Timepoint [13] 99 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [14] 100 0
14. Economic analysis
Timepoint [14] 100 0
Secondary outcomes are measured during the infants stay in the hospital as they occur.
Secondary outcome [15] 101 0
15. Respiratory morbidity
Timepoint [15] 101 0
In the first year after discharge.

Eligibility
Key inclusion criteria
Inborn infants 25 week 0 days to 28 weeks 6 days gestation who breathe at birth & parents consent.
Minimum age
25 Weeks
Maximum age
28 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Babies who have a condition which might compromise respiration. Don't breathe at birth.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be either to nasal CPAP at 8 cm H2O or to intubation and IPPV. Allocation will be assigned randomly using a random number generator and permuted blocks for each centre. This will be produced by the statistical department of the Royal Children's Hospital. Randomisation will be stratified into two gestational age groups: 25 and 26 weeks', and 27 and 28 weeks'. This will reduce any imbalance in gestational age between the groups and allow analysis of the groups seperately. The assinged treatment will be enclosed in sequentially numbered opaque envelopes. There will be a separate set of envelopes for each gestational age stratum in each centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 42 0
Government body
Name [1] 42 0
National Health & Medical Research Council
Country [1] 42 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Women's and Children's Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 36 0
None
Name [1] 36 0
Nil
Address [1] 36 0
Country [1] 36 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 314 0
Ethics committee country [1] 314 0
Australia
Date submitted for ethics approval [1] 314 0
Approval date [1] 314 0
18/03/1999
Ethics approval number [1] 314 0
98/41
Ethics committee name [2] 315 0
Royal North Shore hospital NSH Human Research Ethics Committee
Ethics committee address [2] 315 0
Ethics committee country [2] 315 0
Australia
Date submitted for ethics approval [2] 315 0
Approval date [2] 315 0
Ethics approval number [2] 315 0
0104-051M
Ethics committee name [3] 316 0
Royal Women's Hospital Research Ethics Committee
Ethics committee address [3] 316 0
Ethics committee country [3] 316 0
Australia
Date submitted for ethics approval [3] 316 0
Approval date [3] 316 0
Ethics approval number [3] 316 0
RWH 01/2
Ethics committee name [4] 317 0
Montefiore Medical Centre
Ethics committee address [4] 317 0
Ethics committee country [4] 317 0
Australia
Date submitted for ethics approval [4] 317 0
Approval date [4] 317 0
Ethics approval number [4] 317 0
Ethics committee name [5] 318 0
King Edward Memorial and Princess Margaret Hospital
Ethics committee address [5] 318 0
Ethics committee country [5] 318 0
Australia
Date submitted for ethics approval [5] 318 0
Approval date [5] 318 0
Ethics approval number [5] 318 0
694/EW
Ethics committee name [6] 319 0
Alexandra Hospital
Ethics committee address [6] 319 0
Ethics committee country [6] 319 0
Australia
Date submitted for ethics approval [6] 319 0
Approval date [6] 319 0
01/03/2002
Ethics approval number [6] 319 0
Ethics committee name [7] 320 0
Albert Einstein College of Medicine
Ethics committee address [7] 320 0
Ethics committee country [7] 320 0
United States of America
Date submitted for ethics approval [7] 320 0
Approval date [7] 320 0
20/05/2002
Ethics approval number [7] 320 0
Ethics committee name [8] 321 0
Hackensack University Medical Centre
Ethics committee address [8] 321 0
Ethics committee country [8] 321 0
United States of America
Date submitted for ethics approval [8] 321 0
Approval date [8] 321 0
Ethics approval number [8] 321 0
02.02.102
Ethics committee name [9] 322 0
NICU Gent University Hosptial
Ethics committee address [9] 322 0
Ethics committee country [9] 322 0
Date submitted for ethics approval [9] 322 0
Approval date [9] 322 0
21/01/2003
Ethics approval number [9] 322 0
2002/350
Ethics committee name [10] 323 0
Maternite Regionale Universitaire
Ethics committee address [10] 323 0
Ethics committee country [10] 323 0
Date submitted for ethics approval [10] 323 0
Approval date [10] 323 0
17/04/2003
Ethics approval number [10] 323 0
Ethics committee name [11] 324 0
Rikshospitalet University Hospital
Ethics committee address [11] 324 0
Ethics committee country [11] 324 0
Date submitted for ethics approval [11] 324 0
Approval date [11] 324 0
13/01/2003
Ethics approval number [11] 324 0
S-02275
Ethics committee name [12] 325 0
Univ.-Klinikum Freiburg
Ethics committee address [12] 325 0
Ethics committee country [12] 325 0
Date submitted for ethics approval [12] 325 0
Approval date [12] 325 0
04/12/2003
Ethics approval number [12] 325 0
Nr 278/03
Ethics committee name [13] 326 0
Klinik for Neonatologie Charite Mitte
Ethics committee address [13] 326 0
Ethics committee country [13] 326 0
Date submitted for ethics approval [13] 326 0
Approval date [13] 326 0
06/06/2003
Ethics approval number [13] 326 0
1943/ /Si272

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35682 0
Address 35682 0
Country 35682 0
Phone 35682 0
Fax 35682 0
Email 35682 0
Contact person for public queries
Name 10287 0
Linh Ung
Address 10287 0
The Royal Women's Hospital
University Department of Obstetrics and Gynaecology
132 Grattan Street
Carlton VIC 3053.
Country 10287 0
Australia
Phone 10287 0
03 9344 2609
Fax 10287 0
03 9347 1761
Email 10287 0
[email protected]
Contact person for scientific queries
Name 1215 0
Professor Colin Morley
Address 1215 0
The Royal Women's Hospital
Neonatal Unit 9th Floor
132 Grattan Street
Carlton VIC 3053
Country 1215 0
Australia
Phone 1215 0
03 9344 2527
Fax 1215 0
03 9347 2731
Email 1215 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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