CPAP vs NIPPV: A COMPARATIVE EFFECTIVENESS RESEARCH

NCT04075123 | Completed

• 1 other identifier: 2019-01
• Study Type: observational
• Target: 1,829
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: Investigators aim is to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm neonates and reduce the risk of BPD and SNI. Objectives: Two complementary objectives are proposed. Objective 1: To determine the efficacy and safety of "mandatory non-extubation" until 72 hours of postnatal age for preterm neonates born at 23 -25 weeks' GA who receive mechanical ventilation. Objective 2: To determine whether optimal nasal continuous positive airway pressure post-extubation is as efficacious as nasal intermittent positive pressure ventilation in preterm neonates born at 23 -28 weeks' GA who have received mechanical ventilation.

Conditions

Respiratory Insufficiency Syndrome of Newborn

Keywords

CPAP; NIPPV; INFANT, PREMATURE; RESPIRATORY MANAGEMENT; POST-ESTUBATION

Outcome Measures

Primary Outcomes (1)

• Failure on assigned NRS mode within 72 hours post-initial extubation

  * CPAP arm * Switch to any one of: NIPPV (including NIV-NAVA), or NIHFV * Escalation of CPAP PEEP \>12 cmH2O * Intubation * NIPPV arm * Switch to any one of: NIHFV or NIV-NAVA (for centres that use unsynchronized NIPPV as their primary post-extubation mode) * Escalation of NIPPV beyond any one or more of the maximum allowable settings as described earlier * Switch to CPAP with PEEP \> calculated MAP on NIPPV * Intubation

  72 hours

Secondary Outcomes (11)

• Failure on assigned NRS mode within 7 days post-initial extubation

  7 days

• Need for intubation within 72 hours and 7 days post-initial extubation

  72 hours and 7 days

• Bronchopulmonary dysplasia (BPD) at 36 weeks' PMA

  36 weeks post mestrual age

• Mortality before hospital discharge

  through study completion, an average of 14 weeks

• PMA when off positive pressure support

  through study completion, an average of 14 weeks

Study Arms (2)

CPAP GROUP

Suggested PEEP range 5-10 cmH2O; Minimum required PEEP WILL BE 8 cm water (7 cm water if using bubble CPAP); Maximum allowable† PEEP: 12 cmH2O

Other: CPAP

NIPPV GROUP

Suggested Ranges: PIP 12 to 24 cm water; PEEP 5 to 10 cm water; Rates 20-40 bpm; iTime 0.4-1.0 seconds; Minimum required settings on NIPPV: PEEP 8 cm water; Difference of pressure 6 cm water; Rate 20 bpm; Maximum allowable settings: PEEP 10 cm water; PIP 24 cm water; Rate 60 bpm

Interventions

CPAP OTHER

The two NRS strategies being compared will be initiated at the time of first extubation (NRS support practices prior to initial intubation will be as per local unit guidelines and practices) and all subsequent extubations (if applicable) until 32 weeks PMA. For instance, a unit adopting post-extubation NCPAP strategy will initiate this mode following the initial and all subsequent extubations until 32 weeks PMA whereas centres adopting post-extubation NIPPV will initiate NIPPV following initial and all subsequent extubations until 32 weeks PMA.

Also known as: NIPPV

CPAP GROUP

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates \<29 weeks gestational age (including outborns) who have required mechanical ventilation at any time during their clinical course.

You may qualify if:

• Preterm neonates \<29 weeks gestational age
• Receipt of mechanical ventilation

You may not qualify if:

• Not received mechanical ventilation or active care
• Congenital/genetic/chromosomal anomalies

Sponsors & Collaborators

• Canadian Neonatal Network: lead
• MOUNT SINAI HOSPITAL: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Prakesh Shah, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: October 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)