Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age

NCT02563717 | Completed DMC

• 1 other identifier: 2015/927-31/4
• Study Type: interventional
• Target: 250
• Locations: 5 countries
• Sites: 6

Brief Summary

Trial purpose: For infants born \<28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)? Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born \<28 weeks.

Conditions

Respiration; Insufficient or Poor, Newborn; Infant, Premature, Diseases

Keywords

Resuscitation; Positive-Pressure Respiration; Infant, Extremely Premature; Continuous Positive Airway Pressure; Intubation

Outcome Measures

Primary Outcomes (1)

• Delivery room intubation or death

  The primary outcome is delivery room intubation or death. Death has to be included in the primary outcome since patients that die may not always be intubated. The variable is a dichotomous outcome and reported by the resuscitation team.

  0-30 minutes

Secondary Outcomes (6)

• Time to primary outcome (intubation or death)

  up to 72 hours of age

• Death

  up to 72 hours of age

• Intra ventricular haemorrhage grade III or more

  up to 72 hours of age

• Airleaks and pneumothorax

  up to 72 hours of age

• Failed ventilation

  0-30 minutes

Other Outcomes (12)

• Surfactant use in delivery room (DR) and neonatal intensive care unit (NICU)

  up to 72 hours of age

• The use of positive pressure ventilation (PPV) in delivery room

  0-30 minutes

• Use of sustained inflation (not recommended)

  0-30 minutes

Study Arms (2)

Reference Device: T-piece System

ACTIVE COMPARATOR

Device: T-piece used for respiratory support (several manufacturers)

Investigational Device: The New System

ACTIVE COMPARATOR

Device: New system used for respiratory support

Interventions

T-piece used for respiratory support (several manufacturers) DEVICE

Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Also known as: Neopuff™ Infant T-Piece Resuscitator, T-piece Disposable Circuit Kit (GE Healthcare), Other T-piece manufacturers

Reference Device: T-piece System

New system used for respiratory support DEVICE

Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Also known as: Manufacturing and CE-marking by Inspiration Healthcare, UK

Investigational Device: The New System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Born \<28 weeks gestational age at a university hospital
• Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given

You may not qualify if:

• Decision on treatment limitations before randomisation
• Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
• Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
• Known neuromuscular disease
• No study neonatologist available

Sponsors & Collaborators

• Baldvin Jonsson: lead

Study Sites (6)

Department of neonatology, University Hospital of Iceland

Reykjavik, 101, Iceland

Location

Neonatal Unit, Vilnius University Hospital Santaros Klinikos

Vilnius, LT-08406, Lithuania

Location

Stavanger University Hospital, Department of Pediatrics

Stavanger, 4011, Norway

Location

Department of Neonatology, Poznan University of Medical Sciences

Poznan, 60-535, Poland

Location

University Hospital Linköping, Department of Pediatrics

Linköping, 58185, Sweden

Location

Karolinska University Hospital, Neonatology department

Stockholm, 171 76, Sweden

Location

Related Publications (2)

• Donaldsson S, Palleri E, Jonsson B, Drevhammar T. Transition of Extremely Preterm Infants from Birth to Stable Breathing: A Secondary Analysis of the CORSAD Trial. Neonatology. 2023;120(2):250-256. doi: 10.1159/000528754. Epub 2023 Jan 23.

  PMID: 36689927 DERIVED

• Donaldsson S, Drevhammar T, Li Y, Bartocci M, Rettedal SI, Lundberg F, Odelberg-Johnson P, Szczapa T, Thordarson T, Pilypiene I, Thorkelsson T, Soderstrom L, Chijenas V, Jonsson B; CORSAD Trial Investigators. Comparison of Respiratory Support After Delivery in Infants Born Before 28 Weeks' Gestational Age: The CORSAD Randomized Clinical Trial. JAMA Pediatr. 2021 Sep 1;175(9):911-918. doi: 10.1001/jamapediatrics.2021.1497.

  PMID: 34125148 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Baldvin Jonsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor and Clinical Director Karolinska University HospitalKarolinska University Hospital

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 30, 2015
• Study Start: March 1, 2016
• Primary Completion: May 15, 2020
• Study Completion: May 18, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

PL (1); LI (1); IC (1); SE (2); NO (1)