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Clinical Trials/NCT02967562
NCT02967562CompletedNot Applicable

Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants

King's College London1 site in 1 country63 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
63
Locations
1
Primary Endpoint
Expiratory Tidal Volume

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
0 Minutes to 1 Hour (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Inflation Breaths

Active Comparator

Five 'inflation breaths' lasting two - three seconds

Intervention: Inflation Breaths (Other)

Sustained inflation

Experimental

One fifteen second 'sustained inflation'

Intervention: Sustained Inflation (Other)

Outcomes

Primary Outcomes

Expiratory Tidal Volume

Time Frame: one minute

Expiratory tidal volume during the first minute of resuscitation

Secondary Outcomes

  • End Tidal Carbon Dioxide Level(10 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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