Neonatal Resuscitation - Sustained Inflations
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|ClinicalTrials.gov Identifier: NCT02967562|
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth||Other: Inflation Breaths Other: Sustained Inflation||Not Applicable|
Around 10% of newborns will require some form of assistance after delivery, with babies born more prematurely more likely to require resuscitation
Current UK guidelines advise initial resuscitation with the delivery of five 'inflation breaths' lasting 2-3 seconds with peak inflation pressure of 30cmH2O (20-25cm H2O in premature neonates). Previous studies have shown that despite resuscitation training, clinicians in both simulated and real resuscitation scenarios do not deliver the recommended duration of inflation breaths. This, combined with leaks around the facemask often being as large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus increasing the likelihood of hypoxia and delay in establishing effective respiration.
The use of sustained inflations (up to 15 seconds), rather than intermittent shorter inflation breaths, has shown promising results, with reduction in the need for intubation, and the need for and duration of mechanical ventilation. Around 30% of units in Germany use sustained inflations as first line delivery room management, as do many other hospitals around the world. Resuscitation guidelines from the USA, UK and Europe suggest that sustained inflations should be researched further.
Several studies have shown that for several lengths of inflation breaths, the expired tidal volume achieved is higher if the baby makes respiratory effort during the inflation (active inflation) and that stimulation of spontaneous respiratory effort is a key part in establishing an FRC, enabling spontaneous breathing, and increasing the likelihood of successful resuscitation.
To date, there are no studies directly comparing whether prolonged inflations are more successful at provoking an inspiration than other methods of resuscitation. We therefore aim to compare a 15 second sustained inflation to repeated shorter inflations to determine which is more effective.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||August 2018|
Active Comparator: Inflation Breaths
Five 'inflation breaths' lasting two - three seconds
Other: Inflation Breaths
Experimental: Sustained inflation
One fifteen second 'sustained inflation'
Other: Sustained Inflation
- Expiratory tidal volume [ Time Frame: one minute ]Expiratory tidal volume during the first minute of resuscitation
- End tidal carbon dioxide level [ Time Frame: 10 minutes ]end tidal carbon dioxide level during resuscitation
- Mechanical ventilation [ Time Frame: 72 hours ]Need for mechanical ventilation in first 72 hours
- Adverse effects [ Time Frame: First week of life ]Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967562
|King's College Hospital|
|London, United Kingdom, Se5 9RS|
|Study Director:||Anne Greenough, MD, FRCPCH||King's College London|