The Torpido2 Study: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome

Phase 2

Suspended

• Conditions: Oxidative stress in premature infants; Mortality in premature infants; Bronchopulmonary dysplasia in premature infants; Retinopathy in premature infants; Extreme prematurity; Resuscitation of premature infants; Respiratory - Other respiratory disorders / diseases; Eye - Diseases / disorders of the eye; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12615000115538
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Birth at 23 weeks to 28 weeks 6 days gestation
Signed, written informed consent by parent(s) or legal guardian

Exclusion Criteria

Delivery outside study centre
Any major cardiopulmonary abnormalities that could affect oxygenation or congenital malformations that could affect neuro-developmental outcome
Anticipated inability to follow-up at 2 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without major disability. Major disability is defined by 1. A score below the cut-off indicative of developmental delay on the Ages and Stages Questionnaire (ASQ), 2. Moderate or severe cognitive deficit defined as less than or equal to 80 as assessed by the Bayley Scales of Infant Development III (BSIDIII), or 3. if ASQ or BSIDIII is unavailable, assessment by a medically qualified practitioner documenting at least one of the following: major developmental delay, including language or speech problems; or cerebral palsy with inability to walk unassisted at or after 2 years corrected age; or severe visual loss (cannot fixate/legally blind, or corrected acuity less than 6/60 in both eyes); or deafness requiring a hearing aid or cochlear implant[2 years corrected for gestation]