Assessment of Lung Aeration at Birth

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Brief Title

Assessment of Lung Aeration at Birth

Official Title

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

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%.
    


Study Type

Interventional


Primary Outcome

Difference in bronchopulmonary dysplasia

Secondary Outcome

 Neonatal death < 28 days

Condition

Bronchopulmonary Dysplasia

Intervention

"IPPV group"

Study Arms / Comparison Groups

 "SI group"
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

186

Start Date

May 2013

Completion Date

October 2014

Primary Completion Date

October 2014

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.
      

Gender

All

Ages

N/A - 30 Minutes

Accepts Healthy Volunteers

No

Contacts

Georg Schmolzer, MD,PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01739114

Organization ID

Pro00034524


Responsible Party

Principal Investigator

Study Sponsor

University of Alberta


Study Sponsor

Georg Schmolzer, MD,PhD, Principal Investigator, University of Alberta


Verification Date

March 2017