Condition category
Neonatal Diseases
Date applied
23/07/2013
Date assigned
15/08/2013
Last edited
15/08/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many babies have difficulty breathing after birth. Some of these babies have air collected between their chest wall and the outer surface of the lung. This collection of air is called a pneumothorax. If doctors believe that a pneumothorax is making it difficult for babies to breathe, they remove the air. Most doctors do this by inserting a drain through the chest wall and leaving it in place. Some doctors insert a needle to suck out the air which they then remove. Many infants who have their pneumothorax removed with a needle go on to have a chest drain inserted. It is not known whether it is preferable to do the chest drain immediately or to attempt needle insertion. In this study, we will find this out.

Who can participate?
Newborn babies who are receiving breathing support and have pneumothorax are eligible to participate in the study.

What does the study involve?
Babies will be randomly allocated to have their pneumothorax drained either by needle aspiration or with a chest drain. We will determine how many infants in both groups ultimately have a chest drain insertion. All babies will be followed up until they get discharged from the hospital.

What are the possible benefits and risks of participating?
Both needle aspiration and chest drain insertion are well-accepted methods of draining a pneumothorax. There are no additional risks (above those already encountered by a baby who is receiving breathing support and who is having a pneumothorax drained) by participating in the study. Babies will not have additional tests because they are participating in the study. Fewer infants may have chest drains inserted by participating in the study.

Where is the study run from?
This study run from The National Maternity Hospital, Dublin, Ireland.

When is the study starting and how long is it expected to run for?
The study starts in August 2013 and is expected to last for one year.

Who is funding the study?
The National Children’s Research Centre, Dublin, Ireland.

Who is the main contact?
Dr. Colm O’Donnell
codonnell@nmh.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colm O'Donnell

ORCID ID

Contact details

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
codonnell@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NVD001

Study information

Scientific title

A randomised controlled trial of needle aspiration or chest drain insertion for pneumothorax in newborns

Acronym

NORD

Study hypothesis

In newborn infants with symptomatic pneumothoraces, aspirating air with a needle reduces the need for chest drain insertion.

Ethics approval

Approved by the Ethics Committee at the National Maternity Hospital, Dublin, Ireland on 04.06.2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pneumothorax in newborn infants

Intervention

Aspiration with a 23 or 25 gauge "butterfly" needle and 20mL syringe versus Chest drain insertion.
Acute intervention (up to 15 minutes). Follow-up until hospital discharge.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Chest drain insertion for management of pneumothorax on chest x-ray within 6 hours of diagnosis.

Secondary outcome measures

1. Duration of chest drain
2. Number of chest drain insertions
3. Duration of ventilation post intervention
4. Duration of ventilation
5. Duration of nasal continuous positive airway pressure
6. Duration of supplemental oxygen
7. Bronchopulmonary dysplasia – oxygen treatment at 28 days
8. Chronic lung disease – oxygen treatment at 36 weeks post menstrual age
9. Nosocomial infections
10. Pleural effusions
11. Duration of hospital stay
12. Death before discharge from hospital

Overall trial start date

19/08/2013

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Infants (term and preterm) will be eligible for enrolment in the study if they
1. Have a pneumothorax diagnosed on chest x-ray by treating clinicians
2. Are receiving respiratory support
2.1. Mechanical ventilation (conventional or high frequency oscillation)
2.2. Continuous positive airway pressure (CPAP)
2.3. Supplemental oxygen FiO2 > 40% by head box or nasal cannulae to keep SpO2 >90%
3. The treating clinicians deem the pneumothorax requires treatment

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

70

Participant exclusion criteria

Infants will be excluded from the study if they
1. Do not have respiratory distress
2. Have significant pulmonary hypoplasia, e.g. Potter’s sequence

Recruitment start date

19/08/2013

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Australia, Germany, Ireland, Italy, Netherlands, Norway, Sweden

Trial participating centre

Neonatal Intensive Care Unit,
Dublin
2
Ireland

Sponsor information

Organisation

The National Maternity Hospital (Ireland)

Sponsor details

c/o Colm O'Donnell
Neonatal Intensive Care Unit
Holles Street
Dublin
2
Ireland

Sponsor type

Hospital/treatment centre

Website

http://www.nmh.ie/

Funders

Funder type

Research organisation

Funder name

National Children's Research Centre (Ireland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes