Neonatal Resuscitation - Sustained Inflations

Study Overview
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Brief Summary
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This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.

Detailed Description
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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.

Official Title
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Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants

Conditions
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Premature Birth

Intervention / Treatment
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* Other: Inflation Breaths
* Other: Sustained Inflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born at less than 34 weeks gestation requiring resuscitation at delivery Exclusion Criteria: Major congenital abnormalities Parents have previously expressed lack of consent for study

Ages Eligible for Study
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Minimum Age: 0 Minutes
Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inflation Breaths<br>Five 'inflation breaths' lasting two - three seconds | Other: Inflation Breaths<br> <br> |
| Experimental: Sustained inflation<br>One fifteen second 'sustained inflation' | Other: Sustained Inflation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expiratory Tidal Volume | Expiratory tidal volume during the first minute of resuscitation | one minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Tidal Carbon Dioxide Level | end tidal carbon dioxide level during resuscitation | 10 minutes |