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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65161530
Enrollment
70
Registered
2013-08-15
Start date
2013-08-19
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumothorax in newborn infants Neonatal Diseases Pneumothorax originating in the perinatal period

Interventions

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.

Sponsors

The National Maternity Hospital (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026