A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

NCT03085329 | Unknown DMC FDA Device

• 1 other identifier: Seattle-PAP 002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- \& Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study. The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).

Conditions

Premature Birth

Keywords

bubble nasal continuous positive airway pressure; respiratory support

Outcome Measures

Primary Outcomes (1)

• Failure of noninvasive respiratory support

  The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation. The principal criteria for failure of support are the requirement of an FiO2 greater than 0.40 and CPAP of greater than 6 cm H2O to maintain SaO2 of at least 90%. Support failure also can be declared by the responsible clinician based on best clinical judgment, but any declarations not based on the stated criteria will require written explanations.

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

Secondary Outcomes (8)

• pneumothorax

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

• nasal trauma

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

• supplemental oxygen requirement

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

• ventilation-associated sepsis

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

• death of infant

  After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first.

Study Arms (2)

Seattle-PAP

EXPERIMENTAL

bubble nasal cpap respiratory support with Seattle-PAP bubbler device, with all other aspects of care per usual care noninvasive respiratory support

Device: Seattle-PAP

Conventional bubble nasal CPAP

EXPERIMENTAL

qualified and enrolled infants randomized to this arm will receive noninvasive respiratory support by bubble nasal CPAP, using the Fisher \& Paykel bubbler, which is the standard of care at Nationwide Children's.

Device: Conventional bubble nasal CPAP

Interventions

Seattle-PAP DEVICE

Seattle-PAP is a modified bubble CPAP device that has been given 510(k) clearance by the US FDA (K131502, October 11, 2013) and is thus recognized as substantially equivalent to other approved devices on the market. Results of a recently completed study in infants indicate that Bn-CPAP is associated with lower effort to breathe by spontaneously breathing premature infants.

Seattle-PAP

Conventional bubble nasal CPAP DEVICE

Infants enrolled in the study and randomized to this arm will be given respiratory support by bubble nasal CPAP using the Fisher \& Paykel bubbler device, which is the standard of care at Nationwide Children's.

Conventional bubble nasal CPAP

Eligibility Criteria

• Age: Up to 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure

You may not qualify if:

• Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
• Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (5)

• Diblasi RM, Zignego JC, Tang DM, Hildebrandt J, Smith CV, Hansen TN, Richardson CP. Noninvasive respiratory support of juvenile rabbits by high-amplitude bubble continuous positive airway pressure. Pediatr Res. 2010 Jun;67(6):624-9. doi: 10.1203/PDR.0b013e3181dcd580.

  PMID: 20308940 BACKGROUND

• Welty SE. Continuous Positive Airway Pressure Strategies with Bubble Nasal Continuous Positive Airway Pressure: Not All Bubbling Is the Same: The Seattle Positive Airway Pressure System. Clin Perinatol. 2016 Dec;43(4):661-671. doi: 10.1016/j.clp.2016.07.004.

  PMID: 27837751 RESULT

• Diblasi RM, Zignego JC, Smith CV, Hansen TN, Richardson CP. Effective gas exchange in paralyzed juvenile rabbits using simple, inexpensive respiratory support devices. Pediatr Res. 2010 Dec;68(6):526-30. doi: 10.1203/PDR.0b013e3181f985f0.

  PMID: 20814347 RESULT

• Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.

  PMID: 23944299 RESULT

• Backes CH, Notestine JL, Lamp JM, Balough JC, Notestine AM, Alfred CM, Kern JM, Stenger MR, Rivera BK, Moallem M, Miller RR, Naik A, Cooper JN, Howard CR, Welty SE, Hillman NH, Zupancic JAF, Stanberry LI, Hansen TN, Smith CV. Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial. Trials. 2019 Jan 18;20(1):63. doi: 10.1186/s13063-018-3166-6.

  PMID: 30658678 DERIVED

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

• Carl H Backes, Jr., MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl H Backes, Jr., MD

CONTACT

614 264-6374; carl.backesjr@nationwidechildrens.org

Michael Stenger, MD

CONTACT

614 264-3555; michael.stenger@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of this comparative study makes masking device assignment impractical. The objectivity of the outcome assessment will rely upon adherence to formally defined criteria for device support failure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Principal Investigator

Model Details: With written informed consent from the mother or parents, infants born at less than 30 weeks gestation and who are capable of breathing spontaneously within the first 72 hours postnatal, will be supported by bubble nasal continuous positive airway pressure (Bn-CPAP), randomized to the standard device from Fisher \& Paykel or to Seattle-PAP.

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 21, 2017
• Study Start: February 10, 2017
• Primary Completion: October 31, 2018
• Study Completion: February 9, 2019
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)