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Assessment of Lung Aeration at Birth

Primary Purpose

Bronchopulmonary Dysplasia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
"IPPV group"
SI group
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Lung aeration, Bronchopulmonary dysplasia, Positive Pressure Respiration, Sustained Inflation, Continuous Positive Airway Pressure

Eligibility Criteria

undefined - 30 Minutes (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"SI group"

IPPV group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in bronchopulmonary dysplasia
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
Neonatal death < 28 days
Death before discharge
Death before discharge

Full Information

First Posted
November 27, 2012
Last Updated
March 13, 2017
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01739114
Brief Title
Assessment of Lung Aeration at Birth
Official Title
Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Lung aeration, Bronchopulmonary dysplasia, Positive Pressure Respiration, Sustained Inflation, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"SI group"
Arm Type
Experimental
Arm Description
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.
Arm Title
IPPV group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
"IPPV group"
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SI group
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in bronchopulmonary dysplasia
Description
Difference in bronchopulmonary dysplasia as defined by need for oxygen or respiratory support at 36 weeks corrected gestational age.
Time Frame
36 weeks corrected gestational age
Secondary Outcome Measure Information:
Title
Neonatal death < 28 days
Description
Neonatal death < 28 days
Time Frame
< 28 days
Title
Death before discharge
Description
Death before discharge
Time Frame
before discharge from the NICU

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer, MD,PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5K3V9
Country
Canada

12. IPD Sharing Statement

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Assessment of Lung Aeration at Birth

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