Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neonatal Resuscitation - Sustained Inflations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02967562
Recruitment Status : Completed
First Posted : November 18, 2016
Last Update Posted : October 25, 2018
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Premature Birth Other: Inflation Breaths Other: Sustained Inflation Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants
Study Start Date : November 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : August 2018

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



Primary Outcome Measures :
  1. Expiratory tidal volume [ Time Frame: one minute ]
    Expiratory tidal volume during the first minute of resuscitation


Secondary Outcome Measures :
  1. End tidal carbon dioxide level [ Time Frame: 10 minutes ]
    end tidal carbon dioxide level during resuscitation


Other Outcome Measures:
  1. Mechanical ventilation [ Time Frame: 72 hours ]
    Need for mechanical ventilation in first 72 hours

  2. Adverse effects [ Time Frame: First week of life ]
    Rates of intraventricular haemorrhage, significant patent ductus arteriosus, and pneumothorax



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967562


Locations
Layout table for location information
United Kingdom
King's College Hospital
London, United Kingdom, Se5 9RS
Sponsors and Collaborators
King's College London
King's College Hospital NHS Trust
Investigators
Layout table for investigator information
Study Director: Anne Greenough, MD, FRCPCH King's College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT02967562    
Other Study ID Numbers: KCH16-155
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications