Neonatal Resuscitation - Sustained Inflations

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Other: Sustained Inflation; Other: Inflation Breaths

• Registration Number: NCT02967562
• Lead Sponsor: King's College London

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-08
• Results First Submitted: 2020-01-20
• Results First Submitted QC: 2020-10-20
• Last Update Submitted: 2020-10-20
• Results First Posted: 2020-11-10
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained inflation	Sustained Inflation	One fifteen second 'sustained inflation'
Inflation Breaths	Inflation Breaths	Five 'inflation breaths' lasting two - three seconds

Primary Outcome Measures

Name	Time	Method
Expiratory Tidal Volume	one minute	Expiratory tidal volume during the first minute of resuscitation

Secondary Outcome Measures

Name	Time	Method
End Tidal Carbon Dioxide Level	10 minutes	end tidal carbon dioxide level during resuscitation

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom