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Trial registered on ANZCTR


Registration number
ACTRN12615000115538
Ethics application status
Approved
Date submitted
13/01/2015
Date registered
10/02/2015
Date last updated
8/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Torpido2 Study: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome
Scientific title
The Torpido2 Study: Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: Effects on developmental Outcome
Secondary ID [1] 285954 0
Nil
Universal Trial Number (UTN)
U1111-1166-0066
Trial acronym
Torpido2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress in premature infants 294053 0
Mortality in premature infants 294054 0
Bronchopulmonary dysplasia in premature infants 294055 0
Retinopathy in premature infants 294056 0
Extreme prematurity 294057 0
Resuscitation of premature infants 294058 0
Condition category
Condition code
Respiratory 294182 294182 0 0
Other respiratory disorders / diseases
Eye 294183 294183 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 294184 294184 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised infants are placed on the resuscitation bed and initial care is per local protocol. Adequate lung expansion is achieved with CPAP or ventilation. A pulse oximeter sensor is placed on the right wrist and connected to the Masimo pulse oximeter. Initial FiO2 is set to 0.21. Once oximetry readings are established, FiO2 is adjusted every 30 seconds to achieve target SpO2 values of 80% at 5 minutes and 90% at 10 minutes and after. This is a one off intervention that will last about 20-30 minutes (average duration of respiratory care in the delivery room). Infants may be given pure oxygen (FiO2 1.0) if 1. The infant's heart rate falls below 100 bpm despite adequate ventilation, 2. SpO2 is less than 65% at or after 5 minutes, and/or 3. external cardiac massage or resuscitation medications are required at any time. Management after the infant leaves the delivery room will be as per institutional guidelines.
Intervention code [1] 290924 0
Treatment: Other
Comparator / control treatment
Randomised infants are placed on the resuscitation bed and initial care is per local protocol. Adequate lung expansion is achieved with CPAP or ventilation. A pulse oximeter sensor is placed on the right wrist and connected to the Masimo pulse oximeter. Initial FiO2 is set to 0.6. Once oximetry readings are established, FiO2 is adjusted every 30 seconds to achieve target SpO2 values of 90% at 5 minutes and 95% at 10 minutes and after. This is a one off intervention that will last about 20-30 minutes (average duration of respiratory care in the delivery room). Infants may be given pure oxygen (FiO2 1.0) if 1. The infant's heart rate falls below 100 bpm despite adequate ventilation, 2. SpO2 is less than 65% at or after 5 minutes, and/or 3. external cardiac massage or resuscitation medications are required at any time. Management after the infant leaves the delivery room will be as per institutional guidelines.
Control group
Active

Outcomes
Primary outcome [1] 293972 0
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
Timepoint [1] 293972 0
2 years corrected for gestation
Secondary outcome [1] 312259 0
In hospital survival without Bronchopulmonary Dysplasia (BPD)
Timepoint [1] 312259 0
36 weeks adjusted age
Secondary outcome [2] 312260 0
In-hospital survival without severe Retinopathy of Prematurity (ROP)
Timepoint [2] 312260 0
Discharge from hospital
Secondary outcome [3] 312261 0
Necrotising enterocolitis receiving surgery or causing death
Timepoint [3] 312261 0
Discharge from hospital
Secondary outcome [4] 312262 0
Patent Ductus Arteriosus (PDA) requiring treatment
Timepoint [4] 312262 0
Discharge from hospital
Secondary outcome [5] 320445 0
Late onset sepsis assessed by review of medical records.
Timepoint [5] 320445 0
discharge from hospital
Secondary outcome [6] 320446 0
Duration of hospital stay assessed by review of medical records.
Timepoint [6] 320446 0
Time from birth until discharge home from hospital
Secondary outcome [7] 320447 0
All-cause mortality
Timepoint [7] 320447 0
discharge from hospital
Secondary outcome [8] 326624 0
Weight measured in grams as per each individual hospital's protocol at 36 weeks
Timepoint [8] 326624 0
36 weeks gestational age
Secondary outcome [9] 326625 0
Respiratory morbidity and complications measured as quantitative comparisons of total duration and type of respiratory support as well as occurrence of any of the following: pulmonary hypertension, pulmonary haemorrhage or pneumothorax. This will be assessed by review of medical records.
Timepoint [9] 326625 0
Discharge from hospital
Secondary outcome [10] 326626 0
Spontaneous Intestinal Perforation defined as the infant sustaining an intestinal perforation that is not associated with NEC nor with any bowel abnormality (ex: obstruction, atresia) nor with any mechanical trauma (e.g nasogastric tube). This will be assessed by review of medical records.
Timepoint [10] 326626 0
Discharge from hospital
Secondary outcome [11] 326627 0
Brain Injury defined as grade 3 or 4 intraventricular haemorrhage (on either side of the head) seen on ultrasound according to the system of grading defined by the Australian and New Zealand Neonatal Network (ANZNN) guidelines, or presence by ultrasound of any of the following: periventricular leukomalacia (PVL), porencephalic cysts or hydrocephalus requiring neurosurgical intervention.
Timepoint [11] 326627 0
Discharge from hospital
Secondary outcome [12] 326628 0
Head circumference measured in centimetres as per each individual hospital's protocol.
Timepoint [12] 326628 0
36 weeks gestational age

Eligibility
Key inclusion criteria
Birth at 23 weeks to 28 weeks 6 days gestation
Signed, written informed consent by parent(s) or legal guardian
Minimum age
23 Weeks
Maximum age
28 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be take place through a central web-based randomisation service and treatment allocation will be concealed from parents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation based on the stratification variables site, gestation and multiplicity
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Assuming 77% survival without major disability at 2 years corrected for gestation in the control group, 600 infants per arm (1200 total sample size) yields 80% power for a 7.1% improvement from 77% to 84.1% in survival without major disability at 2 years, with two-tailed 5% significance level, allowing for 10% non-adherence.
Statistical analysis for the primary endpoints of this study will be conducted by the intention to treat principle. Analyses will be based on the GEE extension to the generalized linear model with each measures treated as a binary outcome using a logit link to evaluate the effect of treatment controlling for gestational age stratum. Comparison between treatment arms will be assessed using analysis of variance (ANOVA) models and comparable non-parametric tests for continuous variables and generalized linear models and contingency table procedures (Chi square tests) for categorical variables, controlling for gestational age strata. Linear and generalized regression models will adjust for potential confounders (i.e., demographic and clinical data, site) and evaluate the independent association between oxygen level used for resuscitation at delivery and neuro-developmental outcome. For each outcome measure, model-based approaches will examine whether treatment effects differ across the two gestational age strata, and if so will evaluate treatment effect within strata, although the power to detect such differences is limited.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3314 0
Royal Hospital for Women - Randwick
Recruitment hospital [2] 3315 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [3] 8709 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 8710 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 9097 0
2031 - Randwick
Recruitment postcode(s) [2] 9098 0
2305 - New Lambton
Recruitment postcode(s) [3] 16830 0
2747 - Kingswood
Recruitment postcode(s) [4] 16831 0
4215 - Southport
Recruitment outside Australia
Country [1] 6591 0
New Zealand
State/province [1] 6591 0

Funding & Sponsors
Funding source category [1] 290534 0
Government body
Name [1] 290534 0
National Health and Medical Research Council
Address [1] 290534 0
Level 1
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 290534 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
92-94 Parramatta Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 289227 0
None
Name [1] 289227 0
Address [1] 289227 0
Country [1] 289227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292181 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 292181 0
Research Ethics and Governance Unit
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 292181 0
Australia
Date submitted for ethics approval [1] 292181 0
Approval date [1] 292181 0
04/08/2014
Ethics approval number [1] 292181 0
HREC/14/HNE/212

Summary
Brief summary
Oxygen is necessary for life, but both too much or too little, can damage eyes, lungs and brain. The preterm infant is unique, while their ability to cope with too much oxygen (oxidative stress) is limited, they also need some oxygen after birth because their lungs are not fully developed.

The Torpido2 Study aims to show that preterm infants born at less than 28 completed weeks gestation who have had delivery room resuscitation initiated with 21% (air) followed by lower oxygen targeting until admission to NICU will have improved outcomes when compared with similar infants who have had delivery room resuscitation initiated with 60% oxygen followed by higher oxygen targeting until admission to NICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53958 0
Dr Julee Oei
Address 53958 0
Newborn Care Centre
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 53958 0
Australia
Phone 53958 0
+612 9385 6152
Fax 53958 0
Email 53958 0
j.oei@unsw.edu.au
Contact person for public queries
Name 53959 0
Dr Julee Oei
Address 53959 0
Newborn Care Centre
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 53959 0
Australia
Phone 53959 0
+612 9385 6152
Fax 53959 0
Email 53959 0
j.oei@unsw.edu.au
Contact person for scientific queries
Name 53960 0
Dr Julee Oei
Address 53960 0
Newborn Care Centre
Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 53960 0
Australia
Phone 53960 0
+612 9385 6152
Fax 53960 0
Email 53960 0
j.oei@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results