Clinical trial NCT02967562: 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
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2016-11-18
Enrollment: 63
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Expiratory Tidal Volume
timeFrame: one minute
Secondary outcomes:
measure: End Tidal Carbon Dioxide Level
timeFrame: 10 minutes
Other outcomes:
measure: Mechanical Ventilation
timeFrame: 48 hours
measure: Adverse Effects
timeFrame: First week of life
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Anne Greenough, MD, FRCPCH
role: STUDY_DIRECTOR
References:
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.