Neonatal Resuscitation With Supraglottic Airway Trial

NCT03133572 | Unknown DMC

• 1 other identifier: NeoSupra
• Study Type: interventional
• Target: 1,163
• Locations: 1 country
• Sites: 1

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.

Conditions

Asphyxia Neonatorum

Outcome Measures

Primary Outcomes (1)

• Composite outcome of either a) early neonatal death or b) neonatal encephalopathy

  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).

  Day 7 of life

Secondary Outcomes (7)

• Number of adverse events (AEs) and serious adverse events (SAEs)

  Day 7 of life

• Early neonatal death

  Day 7 of life

• Very early neonatal death

  Day 1 of life

• Neonatal encephalopathy

  Day 7 of life

• Mild neonatal encephalopathy

  Day 7 of life

Study Arms (2)

Supraglottic airway

EXPERIMENTAL

All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a supraglottic airway and a bag.

Device: Supraglottic airway

Face-mask

ACTIVE COMPARATOR

All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a face-mask and a bag.

Device: Face-mask

Interventions

Supraglottic airway DEVICE

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.

Also known as: i-gel, supraglottic airway device

Supraglottic airway

Face-mask DEVICE

In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.

Face-mask

Eligibility Criteria

• Age: Up to 10 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Major malformations (incompatible with sustained life or affecting the airways)

Sponsors & Collaborators

• Centre For International Health: lead
• Makerere University: collaborator
• University of Padova: collaborator
• Karolinska Institutet: collaborator
• Doctors with Africa - CUAMM: collaborator

Study Sites (1)

Mulago National Referral Hospital

Kampala, Uganda

Location

Related Publications (5)

• Pejovic NJ, Trevisanuto D, Nankunda J, Tylleskar T. Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting. Acta Paediatr. 2016 Dec;105(12):1440-1443. doi: 10.1111/apa.13565.

  PMID: 27582031 BACKGROUND

• Pejovic NJ, Trevisanuto D, Lubulwa C, Myrnerts Hook S, Cavallin F, Byamugisha J, Nankunda J, Tylleskar T. Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda. Arch Dis Child. 2018 Mar;103(3):255-260. doi: 10.1136/archdischild-2017-312934. Epub 2017 Sep 14.

  PMID: 28912163 BACKGROUND

• Pejovic NJ, Myrnerts Hook S, Byamugisha J, Alfven T, Lubulwa C, Cavallin F, Nankunda J, Ersdal H, Segafredo G, Blennow M, Trevisanuto D, Tylleskar T. Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. Trials. 2019 Jul 19;20(1):444. doi: 10.1186/s13063-019-3455-8.

  PMID: 31324213 BACKGROUND

• Larsson M, Myrnerts Hook S, Mpamize A, Tylleskar T, Lubulwa C, Trevisanuto D, Elfving K, Pejovic NJ. Oxygen saturation after birth in resuscitated neonates in Uganda: a video-based observational study. BMJ Paediatr Open. 2022 Jan;6(1):e001225. doi: 10.1136/bmjpo-2021-001225.

  PMID: 35258476 DERIVED

• Pejovic NJ, Myrnerts Hook S, Byamugisha J, Alfven T, Lubulwa C, Cavallin F, Nankunda J, Ersdal H, Blennow M, Trevisanuto D, Tylleskar T. A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation. N Engl J Med. 2020 Nov 26;383(22):2138-2147. doi: 10.1056/NEJMoa2005333.

  PMID: 33252870 DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Masks

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Attire; Equipment and Supplies, Hospital; Equipment and Supplies; Protective Devices; Personal Protective Equipment; Surgical Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Thorkild Tylleskär, MD, PhD

  University of Bergen, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The neonatologists assessing the Thompson score will be blinded to the intervention arm. Other staff members will know about the arm allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Day by day, infants will be randomized to either of the arms.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: April 28, 2017
• Study Start: May 8, 2018
• Primary Completion: August 12, 2019
• Study Completion: December 1, 2021
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)