Assessment of Lung Aeration at Birth

March 13, 2017 updated by: Georg Schmolzer, University of Alberta

Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5K3V9
        • Royal Alexandra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 minutes (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in bronchopulmonary dysplasia
Time Frame: 36 weeks corrected gestational age
Difference in bronchopulmonary dysplasia as defined by need for oxygen or respiratory support at 36 weeks corrected gestational age.
36 weeks corrected gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal death < 28 days
Time Frame: < 28 days
Neonatal death < 28 days
< 28 days
Death before discharge
Time Frame: before discharge from the NICU
Death before discharge
before discharge from the NICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ACTUAL)

October 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

November 27, 2012

First Posted (ESTIMATE)

December 3, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00034524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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