Neonatal Resuscitation - Sustained Inflations

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967562
• Other study ID #: KCH16-155
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2018
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Inflation Breaths

• Sustained Inflation

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mechanical Ventilation	Duration of mechanical ventilation ini first 48 hours	48 hours
Other	Adverse Effects	Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax	First week of life
Primary	Expiratory Tidal Volume	Expiratory tidal volume during the first minute of resuscitation	one minute
Secondary	End Tidal Carbon Dioxide Level	end tidal carbon dioxide level during resuscitation	10 minutes