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 Childrens Research Centre, Dublin, Ireland.
Who is the main contact?
Dr. Colm ODonnell
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. Potters 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
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