Neonatal Resuscitation - Sustained Inflations

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

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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Other: Inflation Breaths; Other: Sustained Inflation

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 hour (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Inflation Breaths; Five 'inflation breaths' lasting two - three seconds	Other: Inflation Breaths
EXPERIMENTAL: Sustained inflation; One fifteen second 'sustained inflation'	Other: Sustained Inflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory Tidal Volume	Expiratory tidal volume during the first minute of resuscitation	one minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End Tidal Carbon Dioxide Level	end tidal carbon dioxide level during resuscitation	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Ventilation	Duration of mechanical ventilation ini first 48 hours	48 hours
Adverse Effects	Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax	First week of life

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King's College Hospital NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): March 1, 2018
• Study Completion (ACTUAL): August 1, 2018

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (ESTIMATE): November 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: KCH16-155