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

ISRCTN	ISRCTN94827278
DOI	https://doi.org/10.1186/ISRCTN94827278
Secondary identifying numbers	N/A

Submission date: 23/06/2010
Registration date: 12/07/2010
Last edited: 12/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Janusz Swietlinski
Scientific

Damrota 106
Tychy
43-100
Poland

Phone	+48 (0)608 346 432
Email	j.swietlinski@czd.pl

Study information

Study design	Multicentre randomised unblinded controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	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
Study acronym	NRSPRCT2
Study objectives	We will perform a prospective, randomised clinical trial to test the hypothesis that prophylactic application of non-invasive positive pressure ventilation (NIPPV) infants following surgery who are at high risk of reintubation will reduce extubation failure rate as compared to standard care. Standard care is defined as nasal continuous positive airways pressure (NCPAP) for infants weighing less than 2000 g and oxygen for those larger.
Ethics approval(s)	Bioethical Committee of the Children's Memorial Health Institute, Warsaw, Poland, approved on the 30th October 2009 (ref: 41/KBE/2009)
Health condition(s) or problem(s) studied	Extubation failure in neonates
Intervention	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 (SpO2), and newborns below 2000 g are weaned on NCPAP, 4 cm H2O with FiO2 to achieve adequate SpO2. During the next 360 minutes babies are closely observed for defined risk of weaning failure. Infants with such a risk are randomised to: 1. Control arm: standard therapy - nothing is changed, or 2. Treatment arm: infant flow - NIPPV support Treatment in both arms are continued until failure - intubation, or to time depended on individual clinical condition of the baby. The primary end point is intubation at 48 hours after extubation, the other end points are measured at 72 hours and 7 days after extubation. The observation is closed after 7 days.
Intervention type	Procedure/Surgery
Primary outcome measure	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 outcome measures	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
Overall study start date	28/06/2010
Completion date	30/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	150 babies in each arm of the study (in total 300 babies)
Key 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
Key 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
Date of first enrolment	28/06/2010
Date of final enrolment	30/12/2012

Locations

Countries of recruitment

Poland

Study participating centre

Damrota 106

Tychy
43-100
Poland

Sponsor information

The Great Orchestra of Christmas Charity (Poland)
Charity

ul. Niedzwiedzia 2A
Warszawa
02-737
Poland

Website	http://www.wosp.org.pl
"ROR"	https://ror.org/034dekp80

Funders

Funder type

Charity

The Great Orchestra of Christmas Charity (Poland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan