Assessment of Lung Aeration at Birth

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Georg Schmolzer, University of Alberta
ClinicalTrials.gov Identifier:
NCT01739114
First received: November 27, 2012
Last updated: September 4, 2013
Last verified: May 2013
  Purpose

To determine if respiratory support at birth guided by RFM decreases BPD.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Procedure: "IPPV group"
Procedure: SI group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Difference in bronchopulmonary dysplasia [ Time Frame: 36 weeks corrected gestational age ] [ Designated as safety issue: No ]
    Difference in bronchopulmonary dysplasia as defined by need for oxygen or respiratory support at 36 weeks corrected gestational age.


Secondary Outcome Measures:
  • Neonatal death < 28 days [ Time Frame: < 28 days ] [ Designated as safety issue: No ]
    Neonatal death < 28 days

  • Death before discharge [ Time Frame: before discharge from the NICU ] [ Designated as safety issue: No ]
    Death before discharge


Estimated Enrollment: 186
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "SI group"

Infants randomized into the "SI group" will receive two initial sustained inflations with a PIP of 20 cm H2O.

After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cm H2O and PEEP of 5 cm H2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided.

Procedure: SI group
Infants randomized into the "SI group" will receive two initial sustained inflations with a PIP of 20 cmH2O. After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cmH2O and PEEP of 5 cmH2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided
Active Comparator: IPPV group
Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.
Procedure: "IPPV group"
Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.

Detailed Description:

Despite recent advances in perinatal-neonatal care, there is an increasing trend of bronchopulmonary dysplasia (BPD) among survivors of prematurity1. Most infants developing BPD are born prematurely, and 75% of affected babies weigh less than 1000g at birth2. The risk of developing BPD increases with decreasing birth weight with reported incidence as high as 85% in neonates weighing between 500g and 699g, but only 5% in infants with birth weights over 1500g2. Alberta has the highest rate (10%) of delivering premature infants in Canada. In Edmonton approximately 200 premature infants <1250 g birth weight are born annually and up to 50% will develop BPD. This puts a heavy burden on health resources since these infants require frequent hospital re-admission in the first two years after birth and, even as adolescents have persistent respiratory symptoms.

Hypothesis Preterm infants <33 weeks gestation requiring breathing support at birth, the delivery of SIs (SI group) before mask ventilation compared to standard mask ventilation (IPPV group) will reduce the incidence of BPD.

Aim To determine if respiratory support at birth with initial sustained inflation compared to IPPV decreases BPD.

Study population Entry criteria Infants <33 weeks gestation born in the Royal Alexandra Hospital who require respiratory support for resuscitation in the delivery room.

Exclusion criteria Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, or congenital heart disease requiring intervention in neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.

Description of interventions "SI group" Infants randomized into the "SI group" will receive two initial sustained inflations before PPV or CPAP.

"IPPV group" Infants randomized into the "IPPV group" will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided.

"Failed SI or IPPV" Babies who fail to improve or remain apneic, bradycardic or hypoxemic despite two SIs and/or 30 seconds of effective IPPV require an alternative airway. Unit policy also dictates elective intubation and instillation of surfactant if, despite CPAP, a preterm infant continues to have increased work of breathing or requires a sustained inspiratory oxygen concentration over 40%.

  Eligibility

Ages Eligible for Study:   up to 30 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants <33 weeks gestation born in the Royal Alexandra Hospital who require respiratory support for resuscitation in the delivery room.

Exclusion Criteria:

  • Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, e.g. congenital pulmonary or airway anomalies, congenital diaphragmatic hernia, or congenital heart disease requiring intervention in neonatal period. Infants will also be excluded if their parents refuse to give consent to this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739114

Contacts
Contact: Georg Schmolzer, MD,PhD +1780 735 ext 5179 georg.schmoelzer@me.com

Locations
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5K3V9
Contact: Georg Schmolzer, MD,PhD    1780735 ext 5179    georg.schmoelzer@me.com   
Sub-Investigator: Po-Yin Cheung, MD,PhD         
Sub-Investigator: Khalid Aziz, MD         
Sub-Investigator: Manoj Kumar, MD,PhD         
Principal Investigator: Georg Schmolzer, MD,PhD         
Sub-Investigator: Megan O'Reilly, PhD         
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Georg Schmolzer, MD,PhD University of Alberta
  More Information

Publications:

Responsible Party: Georg Schmolzer, Research Neonatologist, Postdoctoral Fellow, University of Alberta
ClinicalTrials.gov Identifier: NCT01739114     History of Changes
Other Study ID Numbers: Pro00034524
Study First Received: November 27, 2012
Last Updated: September 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Lung aeration
Bronchopulmonary dysplasia
Positive Pressure Respiration
Sustained Inflation
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014