Clinical trial NCT01739114: Assessment of Lung Aeration at Birth
Official title: Sustained Inflations to Achieve Lung Aeration at Birth - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Lung aeration
Bronchopulmonary dysplasia
Positive Pressure Respiration
Sustained Inflation
Continuous Positive Airway Pressure
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 186
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: Difference in bronchopulmonary dysplasia
timeFrame: 36 weeks corrected gestational age
Secondary outcomes:
measure: Neonatal death < 28 days
timeFrame: < 28 days
measure: Death before discharge
timeFrame: before discharge from the NICU
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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