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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflation Breaths | Active Comparator | Five 'inflation breaths' lasting two - three seconds |
|
| Sustained inflation | Experimental | One fifteen second 'sustained inflation' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inflation Breaths | Other |
| ||
| Sustained Inflation |
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory Tidal Volume | Expiratory tidal volume during the first minute of resuscitation | one minute |
| Measure | Description | Time Frame |
|---|---|---|
| End Tidal Carbon Dioxide Level | end tidal carbon dioxide level during resuscitation | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Ventilation | Duration of mechanical ventilation ini first 48 hours | 48 hours |
| Adverse Effects | Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Greenough, MD, FRCPCH | King's College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital | London | Se5 9RS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29179773 | Derived | Hunt KA, Ali K, Dassios T, Milner AD, Greenough A. Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room: a study protocol for a randomised controlled trial. Trials. 2017 Nov 28;18(1):569. doi: 10.1186/s13063-017-2311-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inflation Breaths | Five 'inflation breaths' lasting two - three seconds Inflation Breaths |
| FG001 | Sustained Inflation | One fifteen second 'sustained inflation' Sustained Inflation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inflation Breaths | Five 'inflation breaths' lasting two - three seconds Inflation Breaths |
| BG001 | Sustained Inflation | One fifteen second 'sustained inflation' Sustained Inflation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Expiratory Tidal Volume | Expiratory tidal volume during the first minute of resuscitation | Posted | Median | Full Range | ml/kg/min | one minute |
|
|
Until study completion, maximum of 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inflation Breaths | Five 'inflation breaths' lasting two - three seconds Inflation Breaths |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Anne Greenough | King's College London | 02032999000 | anne.greenough@kcl.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2018 | Oct 17, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| First week of life |
| BG002 | Total | Total of all reporting groups |
| post menstrual weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | End Tidal Carbon Dioxide Level | end tidal carbon dioxide level during resuscitation | Posted | Median | Full Range | mmHg | 10 minutes |
|
|
|
| Other Pre-specified | Mechanical Ventilation | Duration of mechanical ventilation ini first 48 hours | Posted | Median | Full Range | hours | 48 hours |
|
|
|
| Other Pre-specified | Adverse Effects | Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax | Not Posted | First week of life | Participants |
| 3 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Sustained Inflation | One fifteen second 'sustained inflation' Sustained Inflation | 2 | 31 | 0 | 31 | 0 | 31 |
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| D000091642 | Urogenital Diseases |