Neonatal Resuscitation - Sustained Inflations
Primary Purpose
Premature Birth
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inflation Breaths
Sustained Inflation
Sponsored by
About this trial
This is an interventional treatment trial for Premature Birth
Eligibility Criteria
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
Sites / Locations
- King's College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Inflation Breaths
Sustained inflation
Arm Description
Five 'inflation breaths' lasting two - three seconds
One fifteen second 'sustained inflation'
Outcomes
Primary Outcome Measures
Expiratory Tidal Volume
Expiratory tidal volume during the first minute of resuscitation
Secondary Outcome Measures
End Tidal Carbon Dioxide Level
end tidal carbon dioxide level during resuscitation
Full Information
NCT ID
NCT02967562
First Posted
November 15, 2016
Last Updated
October 20, 2020
Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02967562
Brief Title
Neonatal Resuscitation - Sustained Inflations
Official Title
Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inflation Breaths
Arm Type
Active Comparator
Arm Description
Five 'inflation breaths' lasting two - three seconds
Arm Title
Sustained inflation
Arm Type
Experimental
Arm Description
One fifteen second 'sustained inflation'
Intervention Type
Other
Intervention Name(s)
Inflation Breaths
Intervention Type
Other
Intervention Name(s)
Sustained Inflation
Primary Outcome Measure Information:
Title
Expiratory Tidal Volume
Description
Expiratory tidal volume during the first minute of resuscitation
Time Frame
one minute
Secondary Outcome Measure Information:
Title
End Tidal Carbon Dioxide Level
Description
end tidal carbon dioxide level during resuscitation
Time Frame
10 minutes
Other Pre-specified Outcome Measures:
Title
Mechanical Ventilation
Description
Duration of mechanical ventilation ini first 48 hours
Time Frame
48 hours
Title
Adverse Effects
Description
Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax
Time Frame
First week of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Minutes
Maximum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough, MD, FRCPCH
Organizational Affiliation
King's College London
Official's Role
Study Director
Facility Information:
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
Se5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29179773
Citation
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.
Results Reference
derived
Learn more about this trial
Neonatal Resuscitation - Sustained Inflations
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