Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000944831
Ethics application status
Approved
Date submitted
9/06/2021
Date registered
19/07/2021
Date last updated
19/07/2021
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of brain oxygen levels in preterm newborns during three different methods of surfactant administration using a near-infrared spectroscopy device.
Scientific title
Measurement of cerebral oxygenation using Near Infrared spectroscopy when administering Surfactant: A prospective observational study comparing three methods of surfactant administration (NIRSurf study).
Secondary ID [1] 304445 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NIRSurf Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral oxygenation 322262 0
Condition category
Condition code
Neurological 319945 319945 0 0
Studies of the normal brain and nervous system
Reproductive Health and Childbirth 319946 319946 0 0
Complications of newborn
Respiratory 320224 320224 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Upon admission to NICU, the need to administer surfactant therapy will be determined by the attending Neonatologist in three tertiary centers, each using different established protocols for surfactant administration. The same surfactant product will be used at each site.

Site 1: NICU at John Hunter hospital practices surfactant administration soon after birth.
Summary of surfactant administration: Preterm infants are receiving continuous positive airway pressure (CPAP), intubation using an endotracheal tube occurs without premedications, surfactant is administered followed by extubation to CPAP.

Site 2: NICU at Liverpool Hospital administers surfactant using MIST technique.
Summary of surfactant administration: Preterm infants are receiving continuous positive airway pressure (CPAP), intubation using a small catheter (no endotracheal tube and without premedications), surfactant is administered while CPAP is being continued, followed by continuation of CPAP.

In addition to standard clinical monitoring (heart rate, non -invasively monitored blood pressure, oxygen saturation), Near Infra-Red Spectroscopy (NIRS) monitoring (one probe on the left fronto-parietal region) will be commenced 15 minutes before commencing the process for delivering surfactant, continued during surfactant administration and for 24 hours after the procedure. Following this, NIRS monitoring will cease and physiological data collection will end.
Intervention code [1] 320791 0
Diagnosis / Prognosis
Comparator / control treatment
The practice at Westmead Hospital described below will serve as the baseline practice to be compared with surfactant administration practices at John Hunter Hospital and Liverpool Hospital described ealier.

Site 3: NICU at Westmead Hospital administers surfactant using InSurE (Intubation, SURfactant administration, Extubation) method.
Summary of surfactant administration: Preterm infants are receiving CPAP, premedications (fentanyl and atropine) are administered intravenously for analgesia, endotracheal intubation occurs, surfactant is then administered, followed by extubation and continuation of CPAP.
Control group
Active

Outcomes
Primary outcome [1] 327820 0
Cerebral oxygenation changes using Near Infra-red Spectroscopy (NIRS)
Timepoint [1] 327820 0
Continuous monitoring during surfactant delivery
Primary outcome [2] 327821 0
Cerebral oxygenation changes using Near Infra-red Spectroscopy (NIRS)
Timepoint [2] 327821 0
Continual assessment over a 24 hour period immediately following surfactant delivery
Secondary outcome [1] 396700 0
Composite outcome of physiological stability as measured by heart rate (continuous ECG data), blood pressure (via indwelling arterial catheter) and hemoglobin oxygen saturation (via pulse oximetry)
Timepoint [1] 396700 0
Continuous monitoring will be undertaken starting 15 minutes prior to surfactant delivery until completion of surfactant delivery,
Secondary outcome [2] 396701 0
Composite outcome of physiological stability as measured by heart rate (continuous ECG data), blood pressure (via indwelling arterial catheter) and hemoglobin oxygen saturation (via pulse oximetry)
Timepoint [2] 396701 0
Continual monitoring over a 24 hour period immediately following surfactant delivery

Eligibility
Key inclusion criteria
Inborn preterm infants between 26+0 weeks and 31+6 weeks gestation
Minimum age
26 Weeks
Maximum age
31 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lethal or major congenital abnormality
Preterm infants with preterm prolonged rupture of membranes from less than 20 weeks in pregnancy
Preterm infants receiving inotropes
Preterm infants who received CPR at birth or elevated lactate of greater than 10 mMol/L
Preterm infants intubated prior to admission to NICU
Preterm infants with major IVH on the side of cerebral NIRS monitoring as identified on formal cranial ultrasound (Grade III or higher by Papile’s classification)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Demographic and clinical characteristic will be described using standard statistical methods: frequencies and percentages for categorical variables and mean (standard deviation) or median (interquartile range) and range for continuous variables. One way ANOVA will be used to compare the differences in means of cerebral oxygenation using three methods of surfactant administration.
Differences between means, as determined by ANOVA will be reported with p for adjusted F test using the Box conservative epsilon, and p <0.05 will be considered statistically significant. We will calculate mean differences determined using ANOVA with Tukey adjustment between the three methods, 95% confidence intervals and omega squared effect size will be reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
15/09/2023
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19695 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 19696 0
Westmead Hospital - Westmead
Recruitment hospital [3] 19697 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 34327 0
2145 - Westmead
Recruitment postcode(s) [2] 34328 0
2170 - Liverpool
Recruitment postcode(s) [3] 34326 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 308801 0
Hospital
Name [1] 308801 0
Westmead Hospital
Country [1] 308801 0
Australia
Funding source category [2] 309023 0
Hospital
Name [2] 309023 0
John Hunter Children's Hospital
Country [2] 309023 0
Australia
Funding source category [3] 309024 0
Hospital
Name [3] 309024 0
Liverpool Hospital
Country [3] 309024 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
176 Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 309722 0
None
Name [1] 309722 0
Address [1] 309722 0
Country [1] 309722 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308718 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 308718 0
Hunter New England Local Health District
The Lodge, Rankin Park Campus
Locked Bag 1, New Lambton, NSW, 2305
Ethics committee country [1] 308718 0
Australia
Date submitted for ethics approval [1] 308718 0
29/11/2018
Approval date [1] 308718 0
12/03/2019
Ethics approval number [1] 308718 0
2019/ETH01252

Summary
Brief summary
Preterm infants develop respiratory distress syndrome (RDS) soon after birth due to immaturity and lack of surfactant. Several studies have demonstrated the effectiveness of artificial surfactant treatment in improving the outcome from RDS with reduced morbidity and improved survival.

There is significant variation in clinical practice on how surfactant is administered. Traditionally, medications are administered to reduce pain prior to endotracheal intubation for surfactant administration. Several trials have demonstrated that the use of premedication for intubation of the newborn significantly improves intubating conditions, decreases the time and number of attempts needed to complete the intubation procedure, and minimizes the potential for intubation-related airway trauma. However, some centres continue to not use pain medications during this procedure as it can delay extubation and supress spontaneous breathing efforts of the baby. Recently, a minimally invasive surfactant therapy (MIST) has been reported and is used to administer surfactant. This method does not use premedications or endotracheal tube, instead it uses a very small catheter in spontaneously breathing preterm infants.

There is limited knowledge on the effects of the different methods of surfactant administration on brain oxygen levels in preterm infants especially when premedications are not used. This observational study aims to compare the effects of three different methods of surfactant administration on brain oxygen levels in preterm infants born at 26 weeks gestation to 31+6 weeks of gestation. Once a specialist clinician in each participating unit determines the need to administer surfactant treatment, near-infrared spectroscopy (NIRS) monitoring will be started to collect data on brain oxygen levels for infants consented to participate in the study.

Findings of this novel study will significantly improve the understanding and gaps in knowledge of the impact of different ways of administration of surfactant on stability of oxygen delivery to the brain as well as overall physiological stability of the baby.

The study will aim to identify the best method for delivering surfactant to preterm babies with respiratory distress at birth.
Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111658 0
Dr Pranav Jani
Address 111658 0
NICU, Westmead Hospital
176 Hawkesbury Rd, Westmead
NSW 2145
Country 111658 0
Australia
Phone 111658 0
+61 423509440
Fax 111658 0
Email 111658 0
pranav.jani@health.nsw.gov.au
Contact person for public queries
Name 111659 0
Dr Pranav Jani
Address 111659 0
NICU, Westmead Hospital
176 Hawkesbury Rd, Westmead
NSW 2145
Country 111659 0
Australia
Phone 111659 0
+61 423509440
Fax 111659 0
Email 111659 0
pranav.jani@health.nsw.gov.au
Contact person for scientific queries
Name 111660 0
Dr Pranav Jani
Address 111660 0
NICU, Westmead Hospital
176 Hawkesbury Rd, Westmead
NSW 2145
Country 111660 0
Australia
Phone 111660 0
+61 423509440
Fax 111660 0
Email 111660 0
pranav.jani@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Case comparison study. IPD data sharing may be decided in the future.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11993Study protocol  pranav.jani@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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