Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2016-11-30
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inflation Breaths
Five 'inflation breaths' lasting two - three seconds
Inflation Breaths
Sustained inflation
One fifteen second 'sustained inflation'
Sustained Inflation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inflation Breaths
Sustained Inflation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Parents have previously expressed lack of consent for study
0 Minutes
1 Hour
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King's College Hospital NHS Trust
OTHER
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Greenough, MD, FRCPCH
Role: STUDY_DIRECTOR
King's College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
King's College Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KCH16-155
Identifier Type: -
Identifier Source: org_study_id