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

• Register: ANZCTR
• Last refreshed on: 5 September 2022
• Main ID: ACTRN12618000879268
• Date of registration: 25/05/2018
• Prospective Registration: Yes
• Primary sponsor: University of Sydney
• Public title: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on Outcome (TORPIDO 30/60)
• Scientific title: Lower or higher initial oxygen concentration with Targeted Oxygen saturation in Respiratory care of premature Infants at Delivery: effects on Outcome (TORPIDO 30/60)
• Date of first enrolment: 13/09/2018
• Target sample size: 1470
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12618000879268.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 3

Countries of recruitment

Australia, India, Malaysia, Singapore, Spain, United States of America

Contacts

• Name: Dr Ju-Lee Oei

• Name: Ms Trial Coordinator

Key inclusion & exclusion criteria

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

Age minimum: 23 Weeks
Age maximum: 29 Weeks
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Premature infants requiring resuscitation at birth;
Premature infants requiring resuscitation at birth

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

At delivery, a CPAP mask will be applied by the caregiver (e.g. midwife, neonatal clinician, obstetrician, anaesthetist), and initial FiO2 level will be set to 0.6. Using a pulse oximeter, FiO2 will be adjusted as required to achieve target SpO2 (80-85% at 5 min and 85-95% at 10 min and thereafter), until admission to the NICU.

Primary Outcome(s)

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
intraparenchymal lesions, periventricular leukomalacia (PVL) or porencephalic cysts[To 36 weeks gestation]

Secondary Outcome(s)

Tertiary Outcome (Hypothesis Generating) - Number of infants with Patent ductus arteriosus (PDA) will be collected from hospital records. [From birth until discharge home]

Tertiary Outcome (Hypothesis Generating) - Number of infants with necrotising enterocolitis (NEC) confirmed with radiolographs, associated with surgery or death.[From birth until discharge home]

Tertiary Outcome (Hypothesis Generating) - Number of infants with severe retinopathy of prematurity (ROP) as assessed by an ophthalmologist in the neonatal unit.[From birth until discharge home]

Tertiary Outcome (Hypothesis Generating) - Survival without major disability at 2-3 years corrected for gestation. Disability will be assessed by one or more of the following assessments:
a) The Bayley Scales of Infant Development (BSID);
b) The Ages and Stages Questionnaire (ASQ);
c) Short Health Status Questionnaire (SHQ)
The ASQ and SHQ will be collected for all participants, and the BSID will be collected where routinely done.[at 24-36 months corrected age.]

Tertiary Outcome (Hypothesis Generating) - Measured (by pulse oximeter) in 1 minute increments for the first 10 minutes of life and every 5 minutes thereafter until admission to NICU, the time it takes to reach SpO2 greater or equal to 80%[From birth until SpO2 reaches 80%]

Tertiary Outcome (Hypothesis Generating) - Duration of hospital stay defined as the number of days from admission to final discharge home (taken from hospital records). [From birth until discharge home]

All-cause mortality (from hospital records)[Death occurring on any day between birth and discharge home. ]

Tertiary Outcome (Hypothesis Generating) - Endotracheal Intubation in delivery suite required due to depressed respiratory effort (taken from hospital records).[From birth until admission to NICU]

Tertiary Outcome (Hypothesis Generating) - Heart rate at each minute for the first 10 minutes after birth and then every 5 minutes until admission to NICU will be taken from hospital records.[From birth until admission to NICU]

Tertiary Outcome (Hypothesis Generating) - Number of infants with Broncho-pulmonary dysplasia (BPD) defined as requirement for supplemental oxygen or respiratory support survival to 36 weeks, collected from hospital records.[36 weeks gestation.]

Major brain injury from any imaging performed before discharge home. 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 intraparenchymal lesions, periventricular leukomalacia (PVL) or porencephalic cysts[From any imaging performed before discharge home.]

Tertiary Outcome (Hypothesis Generating) - Number of infants with late onset sepsis will be collected from hospital records.[From 48 hours of life until discharge home]

Tertiary Outcome (Hypothesis Generating) - Apgar scores (a summary of the health of the newbown) at 1 and 5 minutes[At 1 and 5 minutes of life]

Tertiary Outcome (Hypothesis Generating) - Number of infants with severe periventricular haemorrhage from any imaging performed before discharge home. [From birth until discharge home]

Tertiary Outcome (Hypothesis Generating) - Oxygen saturation (SpO2) will be monitored using a pulse oximeter until admission to NICU[From birth until admission to NICU]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council

Ethics review

Status: Approved
Approval date: 12/06/2018
Contact:

Hunter New England Local Health Distritct

Status: Approved
Approval date: 02/01/2020
Contact:

HREC of the Northern Territory Department of Health and Menzies School of Health Research