The NORD trial: Needle aspiration OR chest Drain insertion for pneumothorax in newborns

ISRCTN ISRCTN65161530
DOI https://doi.org/10.1186/ISRCTN65161530
Secondary identifying numbers NVD001
Submission date
23/07/2013
Registration date
15/08/2013
Last edited
30/05/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

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

Contact information

Dr Colm O'Donnell
Scientific

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Email codonnell@nmh.ie

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA randomised controlled trial of needle aspiration or chest drain insertion for pneumothorax in newborns
Study acronymNORD
Study objectivesIn newborn infants with symptomatic pneumothoraces, aspirating air with a needle reduces the need for chest drain insertion.
Ethics approval(s)Ethics Committee at the National Maternity Hospital, Dublin, 04/06/2013
Health condition(s) or problem(s) studiedPneumothorax in newborn infants
InterventionAspiration 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 typeProcedure/Surgery
Primary outcome measureChest drain insertion for management of pneumothorax on chest x-ray within 6 hours of diagnosis.
Secondary outcome measures1. 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 study start date19/08/2013
Completion date30/06/2014

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants70
Key inclusion criteriaInfants (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
Key exclusion criteriaInfants will be excluded from the study if they:
1. Do not have respiratory distress
2. Have significant pulmonary hypoplasia, e.g. Potter's sequence
Date of first enrolment19/08/2013
Date of final enrolment30/06/2014

Locations

Countries of recruitment

  • Australia
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Sweden

Study participating centre

The National Maternity Hospital
Dublin
2
Ireland

Sponsor information

The National Maternity Hospital (Ireland)
Hospital/treatment centre

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

Website http://www.nmh.ie/
ROR logo "ROR" https://ror.org/03jcxa214

Funders

Funder type

Research organisation

National Children's Research Centre (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2018 Yes No

Editorial Notes

30/05/2018: Publication reference added.