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Neonatal Resuscitation With Supraglottic Airway Trial (NeoSupra)

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: NCT03133572
Recruitment Status : Active, not recruiting
First Posted : April 28, 2017
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
Makerere University
University of Padova
Karolinska Institutet
Doctors with Africa - CUAMM
Information provided by (Responsible Party):
Centre For International Health

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE April 28, 2017
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE May 8, 2018
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Composite outcome of either a) early neonatal death or b) neonatal encephalopathy [ Time Frame: Day 7 of life ]
A composite outcome of a) early neonatal death (within 7 days) b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Composite outcome of 7-day mortality and neonatal encephalopathy in the first 7 days of life [ Time Frame: Day 7 of life ]
A composite outcome of a) 7-day mortality b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • Number of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Day 7 of life ]
    Safety of i-gel in the hands of non-doctor birth attendants (AEs and SAEs)
  • Early neonatal death [ Time Frame: Day 7 of life ]
    Early neonatal death (within 7 days)
  • Very early neonatal death [ Time Frame: Day 1 of life ]
    Very early neonatal death (within 24 hours)
  • Neonatal encephalopathy [ Time Frame: Day 7 of life ]
    Neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).
  • Mild neonatal encephalopathy [ Time Frame: Day 7 of life ]
    Neonatal encephalopathy (admission to NICU with a Thompson score of 7 or above in day 1-5 during hospitalisation).
  • Any hospital admission [ Time Frame: Day 7 of life ]
    Any hospital admission
  • Advanced resuscitation [ Time Frame: Day 7 of life ]
    Advanced resuscitation including intervention by supervising physician
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neonatal Resuscitation With Supraglottic Airway Trial
Official Title  ICMJE Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Brief Summary

Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.

Detailed Description

One of the targets in the SDG-3 is to reduce neonatal mortality to less than 12 per 1000 live births by 2030. This will require considerable effort in many low-income countries. Perinatal mortality contributes to 40% of infant mortality in Uganda. Early neonatal death from birth asphyxia (BA) could be as high 60%. New evidence-based strategies are needed to reduce mortality from BA in order to achieve SDG-3 by 2030.

Optimal care of the depressed newborn is crucial to prevent and manage BA. The challenge in low-income settings is that highly qualified staff is not readily available to attend to the newborn who require their expertise. In most cases, the midwives are the most skilled personal attending to deliveries and also responsible for resuscitating newborns. At present in low-income settings, FMV is the commonly used method for resuscitating depressed newborn. Easy-to-use equipment such as a supraglottic airway could contribute to obtain more effective ventilation, and improve the outcome of the infant.

This trial is based on a previous pilot trial ClinicalTrials.gov Identifier: NCT02042118.

Primary objective

• To assess if the proportion of either early neonatal death or neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation), can be decreased from 40 % in the control arm (using FM) to 30 % or less in the intervention arm (using i-gel supraglottic airway), a 25% decrease.

Secondary objectives

  • To assess the safety of a supraglottic airway in the hands of lower cadre (non-doctor) birth attendants in Africa.
  • To assess if the proportion of very early and early neonatal deaths is lower in the intervention arm compared to the control arm.
  • To assess if the proportion of neonatal encephalopathy (admission to NICU with maximum Thompson score 11 or above), is lower in the intervention arm compared to the control arm.
  • To assess if the proportion of neonatal encephalopathy (admission to Neonatal Intensive Care Unit - NICU - with maximum Thompson score 7 or above), is lower in the intervention arm compared to the control arm.
  • To assess if hospital admission rate in the first 7 days of life is lower in the intervention arm compared to the control arm.
  • To assess the need of advanced resuscitation in the intervention arm compared to the control arm.

Study justification and significance

Training midwives and other birth-attendants can save lives. However, delivering effective positive pressure ventilation (PPV) with FM is a delicate task that requires continuous (re)training. In a previous phase II trial (NCT02042118), it has been shown that a supraglottic airway is safe to use, even in the hands of midwives and with the potential to deliver efficient PPV and perhaps even improve outcome of asphyxiated babies. The cuffless i-gel is simple to use and could therefore be the ideal device to resuscitate newborn when experienced physicians are not available.

Prior to interventions: training midwives in neonatal resuscitation skills

Helping Babies Breathe (HBB) is an evidence-based educational program to teach neonatal resuscitation techniques in resource-limited areas. It is an initiative of the American Academy of Pediatrics (AAP) in collaboration with the World Health Organization (WHO), US Agency for International Development (USAID), Saving Newborn Lives, the National Institute of Child Health and Development, and a number of other global health organizations.

The objective of HBB is to train birth attendants in developing countries in the essential skills of newborn resuscitation, with the goal of having at least one person who is skilled in neonatal resuscitation at the birth of every baby.

The second edition of HBB is now available and will be used in the training.

Study procedures

It is estimated that around 5-10 % of babies born will need ventilation as part of the resuscitation. This randomized trial will include all babies eligible for resuscitation. All newborns in need of resuscitation will be randomized to receive initial treatment using either:

  • Supraglottic airway (intervention arm) or
  • Face mask (active comparator arm).

The midwife will immediately move the babies not responding to stimulation to the resuscitation area. Ventilation with supraglottic airway or face mask will be initiated immediately. Apgar score and admission to the neonatal ward will be recorded by a research assistant. The intervention may be recorded on video to ensure quality assurance and data collection.

If the infant is hospitalised, daily assessment of Thompson score will be made by a skilled paediatrician/physician. A follow-up visit on day 7 (or later) will determine the outcome (if the infant is alive or not) together with the assessments of Thompson score.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Day by day, infants will be randomized to either of the arms.
Masking: Single (Outcomes Assessor)
Masking Description:
The neonatologists assessing the Thompson score will be blinded to the intervention arm. Other staff members will know about the arm allocation.
Primary Purpose: Treatment
Condition  ICMJE Asphyxia Neonatorum
Intervention  ICMJE
  • Device: Supraglottic airway
    Instead of using a conventional face mask to provide positive pressure ventilation during neonatal resuscitation we are using a supraglottic airway and a conventional bag.
    Other Names:
    • i-gel
    • supraglottic airway device
  • Device: Face-mask
    In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.
Study Arms  ICMJE
  • Experimental: Supraglottic airway
    All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a supraglottic airway and a bag.
    Intervention: Device: Supraglottic airway
  • Active Comparator: Face-mask
    All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a face-mask and a bag.
    Intervention: Device: Face-mask
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
1163
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
1050
Estimated Study Completion Date  ICMJE December 2021
Actual Primary Completion Date August 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Inborn baby (=born in the hospital)
  • Expected ≥ 34-week gestation
  • Expected birth weight ≥ 2000 g
  • Need for PPV at birth
  • Parental consent

Exclusion Criteria:

  • Major malformations (incompatible with sustained life or affecting the airways)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Minutes   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries Mozambique
 
Administrative Information
NCT Number  ICMJE NCT03133572
Other Study ID Numbers  ICMJE NeoSupra
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre For International Health
Study Sponsor  ICMJE Centre For International Health
Collaborators  ICMJE
  • Makerere University
  • University of Padova
  • Karolinska Institutet
  • Doctors with Africa - CUAMM
Investigators  ICMJE
Principal Investigator: Thorkild Tylleskär, MD, PhD University of Bergen, Norway
PRS Account Centre For International Health
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP