Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on Outcome (TORPIDO 30/60)

Phase 3

Recruiting

• Conditions: Premature infants requiring resuscitation at birth; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12618000879268
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-25
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1470

Inclusion Criteria

Premature infants born from 23/0 to 28/6 weeks gestation

Exclusion Criteria

Any known major cardiopulmonary abnormalities that could affect oxygenation or congenital malformations that could affect neuro-developmental outcome or survival

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite primary outcome comprises survival free from major brain injury (assessed by routine ultrasound or other imaging and/or clinical assessment). Brain injury is defined as periventricular haemorrhage (on either side of the head) seen on ultrasound with grade 1-4, or the presence by ultrasound after 14 days of any of the following: echodense<br>intraparenchymal lesions, periventricular leukomalacia (PVL) or porencephalic cysts[To 36 weeks gestation]