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

NCT02563717 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-06-01

No results posted yet for this study

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

Interventions

DEVICE

T-piece used for respiratory support (several manufacturers)

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)

DEVICE

New system used for respiratory support

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)

Sponsors & Collaborators

  • Baldvin Jonsson

    lead OTHER

Principal Investigators

  • Baldvin Jonsson, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-05-15
Completion
2020-05-18

Countries

  • Iceland
  • Lithuania
  • Norway
  • Poland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563717 on ClinicalTrials.gov