Non Invasive Ventilation Versus Continuous Positive Airway Pressure After Extubation of Very Low Birth Weight Infants.

NCT ID: NCT01778829

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-06-30

Brief Summary

The purpose of this study is to determine whether Nasal intermittent positive pressure ventilation (NIPPV) non synchronized is better than continuous positive airway pressure (NCPAP)in preventing extubation failure within 72 h, after extubation of very low birth weight infants at the NEOCOSUR Network.

Detailed Description

Is a Randomized trial to preterms infants <1500g and less than 34 weeks with RDS requiring machanical ventilation in the extubation period, randomized to receive NIPPV or NCPAP once extubation criteria were met. Parental written informed consent is required previous extubation. The failure rate is defined as the need for re-intubation and mechanical ventilation).

Exclusion criteria are: major congenital anomalies; presence of cardiovascular instability;intubation less than 2 hours; mechanical ventilation more than 14 days, using muscle relaxant, airway anomalies, consent not provided or refused.

Outcome measures:

The primary outcome was to assess the need for re-intubation within the first 72 hours after extubation in the 2 groups.

The criteria for failure were met by at least 1 of the following:

pH < 7.25 and PaCO2 > 65 mmHg; recurrent apnea more than 2 episodes per hour associated with bradycardia; during 4 hour continuous; 2 episodes of apnea that required bagand-mask ventilation in any time during the study; or a PaO2 < 50 mm Hg with a fraction of inspired oxygen > 0.6. The secondary outcomes concerning respiratory support were total duration on ETT ventilation, total duration on NCPAP, total duration on supplemental oxygen, incidence of pneumothorax,BPD and dead. Other outcomes included incidence of patent ductus arteriosus (PDA), necrotizing enterocolitis, intraventricular hemorrhage grades 3 and 4, retinopathy of prematurity stage 3, time to full feeds, and length of hospital stay.

Sample size calculations for the primary outcome: We estimated that there would be a more than 80% chance of detecting 43% difference between the groups (alpha 0.05) when samplesize (n) is 110 patients for each mode of treatment.

Conditions

Neonatal Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP ventilation mode

Once the patient is extubated, CPAP ventilation mode is inmediately administered in order to prevent reintubation

Group Type: ACTIVE_COMPARATOR

CPAP ventilation mode

Intervention Type: PROCEDURE

Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure

NIPPV ventilation mode

NIPPV: Non Invasive Ventilation mode is administered inmediately after extubation to prevent reintubation

Group Type: EXPERIMENTAL

NIPPV ventilation mode

Intervention Type: PROCEDURE

Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation

Interventions

CPAP ventilation mode

Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure

Intervention Type: PROCEDURE

NIPPV ventilation mode

Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Preterm with a weight less than 1501 g
• Gestational age less or equal to 34 weeks
• Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
• Patient receiving methylxanthynes

Exclusion Criteria

• Patient more than 14 days in mechanical ventilation
• Newborn with congenital cardiopathy
• Newborn with congenital malformation
• Newborn wirh chromosomopathy or genopathic disease
• Newborn with suspected gastrointestinal disease
• Newborn with neuromuscular disease or receiving muscle relaxants
• Lack or informed consent signed by parents or legal representative

• Minimum Eligible Age: 2 Hours
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Alberto Estay

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alberto Estay, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Hospital Clinico, Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Alberto Estay, MD

Role: CONTACT

albertoestay@gmail.com

56223546437

Alvaro Gonzalez, MD

Role: CONTACT

Facility Contacts

Alberto Estay, MD

Role: primary

albertoestay@gmail.com

Alvaro Gonzalez, MD

Role: backup

alvgonza@med.puc.cl

References

Estay AS, Mariani GL, Alvarez CA, Milet B, Agost D, Avila CP, Roldan L, Abdala DA, Keller R, Galletti MF, Gonzalez A; for the NEOCOSUR Neonatal Network. Randomized Controlled Trial of Nonsynchronized Nasal Intermittent Positive Pressure Ventilation versus Nasal CPAP after Extubation of VLBW Infants. Neonatology. 2020;117(2):193-199. doi: 10.1159/000506164. Epub 2020 May 8.

Reference Type: DERIVED

PMID: 32388511 (View on PubMed)

Other Identifiers

Sa10i20033

Identifier Type: -

Identifier Source: org_study_id