Condition category
Surgery
Date applied
23/06/2010
Date assigned
12/07/2010
Last edited
12/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janusz Swietlinski

ORCID ID

Contact details

Damrota 106
Tychy
43-100
Poland
+48 (0)608 346 432
j.swietlinski@czd.pl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

NRSPRCT2

Study hypothesis

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

Bioethical Committee of the Children's Memorial Health Institute, Warsaw, Poland, approved on the 30th October 2009 (ref: 41/KBE/2009)

Study design

Multicentre randomised unblinded controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

28/06/2010

Overall trial end date

30/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

150 babies in each arm of the study (in total 300 babies)

Participant 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

Recruitment start date

28/06/2010

Recruitment end date

30/12/2012

Locations

Countries of recruitment

Poland

Trial participating centre

Damrota 106
Tychy
43-100
Poland

Sponsor information

Organisation

The Great Orchestra of Christmas Charity (Poland)

Sponsor details

ul. Niedzwiedzia 2A
Warszawa
02-737
Poland

Sponsor type

Charity

Website

http://www.wosp.org.pl

Funders

Funder type

Charity

Funder name

The Great Orchestra of Christmas Charity (Poland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes