Comparing non-invasive respiratory support methods following surgery in neonates with risk of extubation failure

Does non-invasive positive pressure ventilation (NIPPV) support following surgery in neonates gives an advantage over standard oxygen/nasal continuous positive airways pressure (NCPAP) treatment in prevention of extubation failure: a multicentre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN94827278

Enrollment

300

Registered

2010-07-12

Start date

2010-06-28

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Extubation failure in neonates Surgery Extubation failure

Interventions

Extubation following surgery is done according to defined criteria. Newborns above 2000 g are weaned on oxygen with fraction of inspired oxygen (FiO2) to achieve adequate peripheral oxygen saturation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age below 28 days or 44 weeks of corrected age 2. Birth weight greater than or equal to 1500 g 3. Surgery with general anesthesia 4. Baby is unable to wean from respiratory support in the first 6 hours after surgery 5. Parental written consent

Exclusion criteria

Exclusion criteria: 1. Birth weight below 1500 g 2. Congenital defects making nasal prongs useless 3. Serious local (skin, nasal) lesions 4. Resuscitation, shock in last 12 hours before surgery 5. Serious central nervous system (CNS) defects or complications 6. Lethal congenital anomalies 7. Transport to other hospital in first 72 hours after surgery

Design outcomes

Primary

Measure	Time frame
1. Intubation at 48 hours after extubation. Weaning failure criteria as follows: 1.1. SpO2 less than 90% on FiO2 greater than 0.4, or 1.2. pH less than 7.20, or 1.3. PaCO2 greater than 65 mmHg 2. Clinical findings: 2.1. Marked increase in respiratory effort 2.2. Persistent apnea 2.3. Need for bag ventilation 2.4. Frequent apnoeas with bradycardia less than 100/min (lack of respiratory efforts for more than 20 seconds, need for stimulation greater than 3/h) 2.5. Symptoms of multiple organ failure (MOF) 2.6. Attending physician decision	—

Measure

Time frame

1. Intubation at 48 hours after extubation. Weaning failure criteria as follows: 1.1. SpO2 less than 90% on FiO2 greater than 0.4, or 1.2. pH less than 7.20, or 1.3. PaCO2 greater than 65 mmHg 2. Clinical findings: 2.1. Marked increase in respiratory effort 2.2. Persistent apnea 2.3. Need for bag ventilation 2.4. Frequent apnoeas with bradycardia less than 100/min (lack of respiratory efforts for more than 20 seconds, need for stimulation greater than 3/h) 2.5. Symptoms of multiple organ failure (MOF) 2.6. Attending physician decision

—

Secondary

Measure	Time frame
1. Weaning failure at 72 hours after extubation 2. Time of oxygen and respiratory support in weaning phase 3. Complications: pulmonary (PT, PIE, atelectasis), local (skin lesions connected with prongs or tracheal tubes and apneas 4. Length of stay in the ICU and in the hospital	—

Countries

Poland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026