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

Completed

Conditions: Extubation failure
Extubation failure in neonates
Surgery

Registration Number: ISRCTN94827278

Lead Sponsor: The Great Orchestra of Christmas Charity (Poland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Intubation at 48 hours after extubation. Weaning failure criteria as follows: <br>1.1. SpO2 less than 90% on FiO2 greater than 0.4, or <br>1.2. pH less than 7.20, or<br>1.3. PaCO2 greater than 65 mmHg<br>2. Clinical findings: <br>2.1. Marked increase in respiratory effort<br>2.2. Persistent apnea<br>2.3. Need for bag ventilation<br>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)<br>2.5. Symptoms of multiple organ failure (MOF)<br>2.6. Attending physician decision

Secondary Outcome Measures

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