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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06572917




Registration number
NCT06572917
Ethics application status
Date submitted
19/08/2024
Date registered
27/08/2024

Titles & IDs
Public title
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
Scientific title
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants - A Multicenter Randomized Blinded Placebo-Controlled Trial (the SPIN RCT)
Secondary ID [1] 0 0
H24-02525
Universal Trial Number (UTN)
Trial acronym
SPIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extreme Prematurity 0 0
Intraventricular Hemorrhage 0 0
Morbidity;Newborn 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Indomethacin
Treatment: Drugs - Placebo

Experimental: Single-dose prophylactic indomethacin - SPIN - Infants randomized to the SPIN group will receive a single 0.1 mg/kg dose of intravenous indomethacin within 12h of birth as a slow infusion over 20 mins.

Placebo comparator: Control - Equal volume saline placebo administered intravenously over 20 mins


Treatment: Drugs: Indomethacin
Single dose of 0.1 mg/kg dose intravenous indomethacin as a slow infusion over 20 mins

Treatment: Drugs: Placebo
Single dose of intravenous normal saline placebo as a slow infusion over 20 mins
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival without severe intraventricular hemorrhage (sIVH)
Timepoint [1] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [2] 0 0
Severe IVH
Timepoint [2] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [3] 0 0
Gastrointestinal perforation
Timepoint [3] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [4] 0 0
Necrotizing enterocolitis (NEC)
Timepoint [4] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [5] 0 0
Acute kidney injury (AKI)
Timepoint [5] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [6] 0 0
Persistent patent ductus arteriosus
Timepoint [6] 0 0
7 days postnatal age
Secondary outcome [7] 0 0
Procedural PDA closure
Timepoint [7] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [8] 0 0
Chronic pulmonary hypertension
Timepoint [8] 0 0
birth through 36 weeks' postmenstrual age (PMA)
Secondary outcome [9] 0 0
Grade 3 Bronchopulmonary dysplasia (BPD)
Timepoint [9] 0 0
birth through 36 weeks' postmenstrual age (PMA)
Secondary outcome [10] 0 0
Pulmonary hemorrhage
Timepoint [10] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [11] 0 0
Duration of invasive mechanical ventilation in days
Timepoint [11] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [12] 0 0
Postnatal corticosteroid use
Timepoint [12] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [13] 0 0
IVH (any grade)
Timepoint [13] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [14] 0 0
Periventricular leukomalacia (any grade)
Timepoint [14] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [15] 0 0
White matter injury (WMI)
Timepoint [15] 0 0
Term corrected age (approximately 20 weeks postnatal age)
Secondary outcome [16] 0 0
Severe retinopathy of prematurity (ROP)
Timepoint [16] 0 0
through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)
Secondary outcome [17] 0 0
Major neurodevelopmental impairment
Timepoint [17] 0 0
24 (±6) months postmenstrual age (PMA)

Eligibility
Key inclusion criteria
* Extremely preterm infants born <26 completed weeks of GA and/or extremely low BW infants born <750g
Minimum age
0 Hours
Maximum age
12 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* antenatal diagnosis of duct dependent CHD
* acute hypoxic respiratory failure [defined as fraction of inspired oxygen (FiO2)>0.60 for =2h)
* inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)
* receipt of prophylactic or therapeutic hydrocortisone
* antenatal diagnosis of renal anomalies
* initial platelet count <50x109/L
* decision to withhold/withdraw life-sustaining treatments

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Children's Hospital - Melbourne
Recruitment hospital [2] 0 0
The Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
University of British Columbia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Souvik Mitra, MD, PhD
Address 0 0
University of British Columbia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Souvik Mitra, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
6048752000
Fax 0 0
Email 0 0
souvik.mitra@cw.bc.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data on clinical outcomes collected during the trial will be shared after deidentification.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
As soon as possible, wherever legally and ethically possible. In addition, data from the trial will be made available upon reasonable request.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06572917