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Trial registered on ANZCTR


Registration number
ACTRN12618000621213
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
20/04/2018
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Resuscitating newborn infants with the umbilical cord intact- The Baby-Directed Umbilical Cord Cutting (Baby-DUCC) Trial

Scientific title
Resuscitation of term and near-term infants with the umbilical cord intact for improving physiological transition at birth- a randomised trial.
Secondary ID [1] 294565 0
None
Universal Trial Number (UTN)
U1111-1212-1988
Trial acronym
Baby-DUCC Physiology RCT
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Neonatal transition 307340 0
Neonatal resuscitation 307341 0
Birth asphyxia 307342 0
Umbilical cord clamping 307343 0
Condition category
Condition code
Reproductive Health and Childbirth 306449 306449 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 306526 306526 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Establishment of ventilation, either via positive pressure ventilation or effective spontaneous breathing, prior to umbilical cord clamping, as detailed below.

All infants will be assessed for the need for respiratory support after birth per Australian Neonatal Resuscitation guidelines by the paediatrician in attendance at the delivery. If the infant requires respiratory support after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures).
If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. Infants must be randomised prior to 60 seconds after delivery to be included in the primary analysis. All monitoring initiated for the purpose of the study will be easily visible to the care team and can be used for evaluation of the infant.
If the non-vigorous infant is randomised to Baby-DUCC, respiratory support will be provided using a portable respiratory support system located on a mobile pole equipped with a T-Piece, oxygen blender, and suction catheter. In a vaginal delivery, the infant will be placed on a portable mattress on the end of the bed. If the end of the bed has been removed (i.e. the mother is in stirrups for an instrumental delivery) then the mattress will be placed in a portable cot and positioned between the mother’s legs. If respiratory support is indicated, positive pressure ventilation or CPAP, can be provided the respiratory support pole. A disposal colorimetric exhaled carbon dioxide detector (pedicap or neostat) will be placed between the facemask and T-Piece. Colour change indicates exhaled carbon dioxide
is greater than or equal to 15mmHg, and will be monitored by the researcher. If the infant receives PPV, umbilical cord clamping will be delayed until at least 60 seconds after colour change of the pedicap/neostat has occurred. If the infant receives CPAP only, umbilical cord clamping occurs at at least 2 minutes after delivery. The duration of respiratory support will be determined by the clinical team and will follow standard clinical practice. Oxytocin for the prevention of postpartum haemorrhage will be administered after umbilical cord clamping.

All interventions, including the provision of resuscitation, umbilical cord clamping and clinical decision making will be by the clinical team. The researcher will be responsible for the application of ECG leads and collection of monitoring data. The researcher will be available for medical assistance if requested by the clinical team.

Deviations from adherence to the study protocol will be documented by researcher. A video camera will be focused on the monitor to verify accuracy of the recorded data (plethysmography wave form or QRS complex). Audio recording from the video camera or additional audio recorder will be used to verify accurately events during delivery, for example the timing of umbilical cord clamping, the time to initiate breathing, and the timing of pedicap/neostat colour change.
Intervention code [1] 300858 0
Treatment: Other
Comparator / control treatment
Immediate cord clamping if the infant requires resuscitation
Control group
Active

Outcomes
Primary outcome [1] 305462 0
Average heart rate between 60-120 seconds after birth determined by ECG
Timepoint [1] 305462 0
60-120 seconds after birth
Secondary outcome [1] 345313 0
Time from birth to umbilical cord clamping (directly measured by researcher by monitoring of APGAR clock and verified from review of the audio recording)
Timepoint [1] 345313 0
Within 10 minutes of birth
Secondary outcome [2] 345314 0
Time from birth to 1st cry (directly measured by researcher by monitoring of APGAR clock and verified from review of the audio recording)
Timepoint [2] 345314 0
Within 10 minutes of birth
Secondary outcome [3] 345315 0
Time from birth to initiate respiratory support (directly measured by researcher by monitoring of APGAR clock and verified from review of the audio recording)
Timepoint [3] 345315 0
Within 10 minutes of birth
Secondary outcome [4] 345316 0
Time from birth to pedicap/neostat colour change, if the infant receives respiratory support (directly measured by researcher by monitoring of APGAR clock and verified from review of the audio recording)
Timepoint [4] 345316 0
Within 10 minutes of birth
Secondary outcome [5] 345317 0
Time from birth to oxytocin delivery to the mother if administered (directly measured by researcher by monitoring of APGAR clock and verified from review of the audio recording).
Timepoint [5] 345317 0
Within 10 minutes of birth.
Secondary outcome [6] 345319 0
Time from birth to obtain accurate data from the ECG or pulse oximeter (from review of the video recording of the observation monitor)
Timepoint [6] 345319 0
Within 10 minutes of birth.
Secondary outcome [7] 345321 0
Proportion of infants receiving resuscitation measures: CPAP, PPV, oxygen, intubation, chest compressions (composite outcome, documented by researcher by observation of resuscitation)
Timepoint [7] 345321 0
During the first 10 minutes after delivery
Secondary outcome [8] 345322 0
Maximum fraction of inspired oxygen (to be read off the oxygen blender by the researcher during resuscitation)
Timepoint [8] 345322 0
Whilst in the delivery room
Secondary outcome [9] 345323 0
Apgar scores as a measure of overall infant well-being in the delivery room
Timepoint [9] 345323 0
1, 5 and 10 minutes
Secondary outcome [10] 345324 0
First temperature measured by digital under-arm thermometer
Timepoint [10] 345324 0
Within the 1 hour after delivery
Secondary outcome [11] 345325 0
Results of umbilical cord blood gases if available. Cord blood will be taken by the clinical team and analysed in the biochemistry laboratory as per standard practice.
Timepoint [11] 345325 0
When measured- sampling is usually done with 30 minutes of birth.
Secondary outcome [12] 345326 0
Rates of successful umbilical cord blood donation as applicable. The volume and quality of blood donated will be independently assessed by the Blood Bank service, blinded to the randomisation arm.
Timepoint [12] 345326 0
Cord blood will be taken within 1 hour of delivery of the placenta.
Secondary outcome [13] 345327 0
Proportion admitted to the neonatal unit (from review of medical records)
Timepoint [13] 345327 0
Prior to hospital discharge
Secondary outcome [14] 345333 0
Birth weight, measures on hospital electronic weighing scales. Data to be collected from review of medical records.
Timepoint [14] 345333 0
Day 1 after birth
Secondary outcome [15] 345334 0
Proportion of infants receiving phototherapy (from review of medical records)
Timepoint [15] 345334 0
Within 7 days after birth
Secondary outcome [16] 345335 0
Proportion of infants treated for polycythaemia (from review of medical records)
Timepoint [16] 345335 0
Within 7 days after birth
Secondary outcome [17] 345366 0
Postpartum haemorrhage >500ml (from review of medical records)
Timepoint [17] 345366 0
24 hours after delivery
Secondary outcome [18] 345367 0
Proportion with retained placenta (from review of medical records)
Timepoint [18] 345367 0
During maternal admission
Secondary outcome [19] 345368 0
Maternal infections acquired during delivery (from review of medical records)
Timepoint [19] 345368 0
During maternal admission
Secondary outcome [20] 345632 0
Proportion of infants receiving an exchange transfusion (from review of medical records)
Timepoint [20] 345632 0
Within 7 days after birth
Secondary outcome [21] 345634 0
Haematocrit level if measured (from medical records)
Timepoint [21] 345634 0
On day 1 of life
Secondary outcome [22] 345635 0
Post-partum haemorrhage >1000ml (from review of medical records)
Timepoint [22] 345635 0
Within 24 hours of delivery
Secondary outcome [23] 345636 0
Post-partum haemorrhage requiring blood product transfusion (from review of medical records)
Timepoint [23] 345636 0
Within 24 hours of delivery
Secondary outcome [24] 345771 0
Reason for admission to the neonatal unit (from review of medical records)
Timepoint [24] 345771 0
Prior to hospital discharge
Secondary outcome [25] 348364 0
Time to regular respirations (called out by researcher during observation of resuscitation and documented during audio/video review).
Timepoint [25] 348364 0
During the first 10 minutes after delivery
Secondary outcome [26] 348365 0
Proportion of infants with heart rate <100 beats per minute from the ECG or pulse oximeter (from review of the video recording of the observation monitor).
Timepoint [26] 348365 0
During the first 10 minutes after delivery
Secondary outcome [27] 348366 0
Time spent with heart rate < 100 beats per minute from the ECG or pulse oximeter (from review of the video recording of the observation monitor).
Timepoint [27] 348366 0
During the first 10 minutes after delivery
Secondary outcome [28] 348367 0
Time spent with heart rate >180 beats per minute from the ECG or pulse oximeter (from review of the video recording of the observation monitor).
Timepoint [28] 348367 0
During the first 10 minutes after delivery
Secondary outcome [29] 348368 0
Variability of heart rate for individuals in each group- data from the ECG or pulse oximeter (from review of the video recording of the observation monitor). This will be by comparison of the standard deviations of heart rate for infants in each group.
Timepoint [29] 348368 0
During the first 10 minutes after delivery
Secondary outcome [30] 348369 0
Change in heart rate over time- data from the ECG or pulse oximeter (from review of the video recording of the observation monitor).
Timepoint [30] 348369 0
During the first 5 minutes after birth
Secondary outcome [31] 348370 0
Change in SpO2 over time- data from the ECG or pulse oximeter (from review of the video recording of the observation monitor).
Timepoint [31] 348370 0
During the first 5 minutes after birth.

Eligibility
Key inclusion criteria
Infants greater than or equal to 32 weeks’ gestation, with a request for a paediatrician to attend the delivery for potential newborn distress, born at the participating centres, are eligible for inclusion. The intervention arm (Baby-DUCC) requires that maternal oxytocin administration will occur at between 2 and 5 minutes after delivery. Assessment of the need for early maternal oxytocin administration after delivery, and permission from the maternal care team prior to recruitment and enrolment is required.
Minimum age
0 Hours
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will not approach expecting mothers of monochorionic twins and multiples of >2, fetuses with known congenital anomalies compromising cardiorespiratory transition after birth, including congenital diaphragmatic hernia, hydrops fetalis, cyanotic congenital heart defects, and airway anomalies that may compromise the ability to provide face mask PPV.
If the maternal treatment team feels that the mother is at high risk for obstetric complications that may be exacerbated by the study intervention, and/or requires early oxytocin administration after delivery, they will not be approached for consent. Potential maternal obstetric complications that may meet criteria for exclusion from the study at the discretion of the maternal care team include abnormal placentation, suspected placental abruption, suspected uterine rupture, significant blood loss, and coagulopathy.

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)
The randomisation tables will be incorporated into the REDCap randomisation tool (hosted by the Murdoch Children’s Research Institute). A weblink to the tool will be accessed via a mobile device at delivery and enables randomisation to be completed within seconds of the the clinical team's decision to commence resuscitation. This decision must be made within 60 seconds of delivery of the infant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated, random block sizes will be used with stratification (see below).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Infants will be stratified by gestational age (32-35 weeks, or greater than or equal to 36 weeks at birth). Infants greater than or equal to 36 weeks gestation at birth will also be stratified into non-emergent and emergent deliveries. Emergent deliveries include emergent caesarean sections (“code green”) and vaginal instrumental deliveries. We anticipate that 30% of infants recruited will be 32-35 weeks, 35% to be greater than or equal to 36 weeks delivered emergently, and 35% to be greater than or equal to 36 weeks delivered non-emergently.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Infant characteristics will be presented as numbers and proportions for categorical variables, means and SDs for normally distributed continuous variables, and medians and IQRs for variables with skewed distribution. Pulse oximetry data and ECG will only be used if the signal is determined to be accurate based on visible video recording of plethysmograph wave form or QRS complex that shows good quality signal, or concurrent Doppler ultrasound heartbeat.

For the primary outcome, the average heart rate between 60-120 seconds after birth for each patient will be calculated, and compared is a comparison of mean heart rate between intervention groups using , analysed via an independent t-test. Imbalances in the randomised strata will be adjusted for using linear regressionThe primary outcome is a comparison of mean heart rate between intervention groups, analysed via an independent t-test. Continuous heart rate and SpO2 values over upto the first 10 minutes after delivery will be collected, and trends compared between groups using two-way mixed ANOVA or linear mixed methods regression depending on completeness of data. Continuous variables will be compared using an independent samples t-test if normally distributed and a 2-sided Mann-Whitney U test for non-normally distributed data. Categorical variables will be compared using the Fisher’s exact test. Statistical significance will be considered at p<0.05. Subgroup analyses for each stratum are planned for the primary outcome.

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 10628 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 10629 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 22346 0
3168 - Clayton
Recruitment postcode(s) [2] 22347 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 299184 0
Government body
Name [1] 299184 0
National Health And Medical Research Council Program Grant
Address [1] 299184 0
16 Marcus Clarke Street
Canberra, ACT 2601
Country [1] 299184 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
20 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 298447 0
Hospital
Name [1] 298447 0
Monash Medical Centre
Address [1] 298447 0
246 Clayton Rd, Clayton VIC 3168
Country [1] 298447 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300108 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 300108 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton, Victoria 3168
Ethics committee country [1] 300108 0
Australia
Date submitted for ethics approval [1] 300108 0
01/02/2018
Approval date [1] 300108 0
19/04/2018
Ethics approval number [1] 300108 0
HREC/18/MonH/19
Ethics committee name [2] 300731 0
The Royal Women's Hospital Human Research and Ethics Committee
Ethics committee address [2] 300731 0
20 Flemington Rd, Parkville VIC 3052
Ethics committee country [2] 300731 0
Australia
Date submitted for ethics approval [2] 300731 0
Approval date [2] 300731 0
01/06/2018
Ethics approval number [2] 300731 0
17/19

Summary
Brief summary
Participants: In infants greater than or equal to 32 weeks gestational age at birth who require resuscitation at delivery,
Intervention: Does establishing effective ventilation, either via PPV or effective spontaneous breathing, prior to umbilical cord clamping* versus
Comparator: Standard care- immediate cord clamping followed by resuscitation
Outcome: Result in a higher average heart rate between 60-120 after birth.

*In the intervention arm (Baby-DUCC), infants that receive PPV will have umbilical cord clamping at least 1 minute after pedicap/neostat colour change, or at least 2 minutes after delivery, which ever time occurs last. Pedicap/neostat colour change indicates exhaled carbon dioxide levels are greater than or equal to 15mmHg, therefore, the lungs are aerated and pulmonary gas exchange has begun. If the infant is still receiving PPV at 5 minutes, the umbilical cord will be cut and the infant will be moved to the warming bed.

If the infant requires respiratory support after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect heart rate and SpO2 data in the first 10 minutes after birth.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2796 2796 0 0

Contacts
Principal investigator
Name 82594 0
Dr Shiraz Badurdeen
Address 82594 0
Newborn Research Centre, Level 7, Royal Women's Hospital, 20 Flemington Rd, Parkville VIC 3052
Country 82594 0
Australia
Phone 82594 0
+61 3 8345 3763
Fax 82594 0
Email 82594 0
shiraz.badurdeen@thewomens.org.au
Contact person for public queries
Name 82595 0
Dr Shiraz Badurdeen
Address 82595 0
Newborn Research Centre, Level 7, Royal Women's Hospital, 20 Flemington Rd, Parkville VIC 3052
Country 82595 0
Australia
Phone 82595 0
+61 3 8345 3763
Fax 82595 0
Email 82595 0
shiraz.badurdeen@thewomens.org.au
Contact person for scientific queries
Name 82596 0
Dr Shiraz Badurdeen
Address 82596 0
Newborn Research Centre, Level 7, Royal Women's Hospital, 20 Flemington Rd, Parkville VIC 3052
Country 82596 0
Australia
Phone 82596 0
+61 3 8345 3763
Fax 82596 0
Email 82596 0
shiraz.badurdeen@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD may be made available upon request and at the discretion of the Trial Steering Committee.
What supporting documents are/will be available?
No other documents available
Summary results
No Results