A randomized controlled trial of respiratory function monitoring during stabilization of preterm infants at birth

A randomized controlled trial of respiratory function monitoring during stabilization of preterm infants at birth - MONitoR-trial (MOnitoring Neonatal Resuscitation- trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37164

Enrollment

100

Registered

2013-03-20

Start date

2013-10-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress syndrome in preterm infants at birth

Interventions

Eligible infants will be randomised to either have the respiratory function monitor visible or covered during positive pressure ventilation for resuscitation at birth

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Infants born will be included in this study if they are between 24 and 27 completed weeks gestation receiving PPV for resuscitation at birth

Exclusion criteria

Exclusion criteria: if they are found to have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation, including: congenital diaphragmatic hernia, tracheo-oesophageal fistula or cyanotic heart disease.

Design outcomes

Primary

Measure	Time frame
The proportion of tidal volumes delivered during manual PPV to an infant within the target range of safe tidal ventilation. The target range of adequate tidal volume is defined as 4-8 mL/kg.	—

Secondary

Measure	Time frame
Secondary outcomes: clinical - Rates of endotracheal intubation in the first 24 hours after birth - The need for circulatory support over first 24 hours (inotropes and fluid boluses) - Incidence of air leak (pneumothorax, pulmonary interstitial emphysema,or pneumomediastinum) in the first 72 hours, reported by a radiologist masked to the intervention. - Incidence of abnormal cranial ultrasound findings (i) all intraventricular haemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular haemorrhage, (iii) periventricular leukomalacia - Duration of endotracheal (ET) ventilation (hours). - Duration of nasal CPAP (hours). - Duration of supplemental oxygen therapy (hours) - Total duration of assisted ventilation (ET, CPAP) in hours - Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support. The severity of BPD will be assessed as proposed by Jobe et al.34 and oxygen reduction test will be performed in case of moderate BPD as described by Walsh et al35. - Neonatal mortality - death before discharge from hospital. - Composite outcome of death or BPD Secondary outcomes: physiological and biochemical measurements 1. Oximetry data on SpO2 and heart rate in the first 10 minutes from birth will be downloaded 2. Duration of significant mask leak (defined as > 60 %) as a proportion of time face mask was used. 3. Significant airway obstruction (defined as a reduction in flow and volume (	—

Measure

Time frame

Secondary outcomes: clinical - Rates of endotracheal intubation in the first 24 hours after birth - The need for circulatory support over first 24 hours (inotropes and fluid boluses) - Incidence of air leak (pneumothorax, pulmonary interstitial emphysema,or pneumomediastinum) in the first 72 hours, reported by a radiologist masked to the intervention. - Incidence of abnormal cranial ultrasound findings (i) all intraventricular haemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular haemorrhage, (iii) periventricular leukomalacia - Duration of endotracheal (ET) ventilation (hours). - Duration of nasal CPAP (hours). - Duration of supplemental oxygen therapy (hours) - Total duration of assisted ventilation (ET, CPAP) in hours - Incidence of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support. The severity of BPD will be assessed as proposed by Jobe et al.34 and oxygen reduction test will be performed in case of moderate BPD as described by Walsh et al35. - Neonatal mortality - death before discharge from hospital. - Composite outcome of death or BPD Secondary outcomes: physiological and biochemical measurements 1. Oximetry data on SpO2 and heart rate in the first 10 minutes from birth will be downloaded 2. Duration of significant mask leak (defined as > 60 %) as a proportion of time face mask was used. 3. Significant airway obstruction (defined as a reduction in flow and volume (

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)