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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
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth

Eligibility Criteria

0 Minutes - 1 Hour (Child)All SexesDoes not accept healthy volunteers

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

First Posted
November 15, 2016
Last Updated
October 20, 2020
Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
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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

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Neonatal Resuscitation - Sustained Inflations

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