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Trial registered on ANZCTR


Registration number
ACTRN12617000610336
Ethics application status
Approved
Date submitted
2/03/2017
Date registered
28/04/2017
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Baby-Directed Umbilical Cord Clamping Feasibility Study: The Baby-DUCC Feasibility Study
Scientific title
The Baby-Directed Umbilical Cord Clamping Feasibility Study: The Baby-DUCC Feasibility Study
Secondary ID [1] 291337 0
None
Universal Trial Number (UTN)
Trial acronym
Baby-DUCC Feasibility Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal resuscitation 302322 0
Umbilical cord management 302323 0
Condition category
Condition code
Reproductive Health and Childbirth 301904 301904 0 0
Complications of newborn
Reproductive Health and Childbirth 301905 301905 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this non-randomized feasibility study is to gain experience providing baby-directed umbilical cord clamping (BABY-DUCC) in newborn infants, born at 28 weeks or later, immediately after birth. BABY-DUCC is delaying umbilical cord clamping after birth to maintain placental circulation and gas exchange and provide respiratory support (if indicated) until lung aeration and pulmonary gas exchange has begun indicating successful neonatal adaption after delivery.

This will be a single centre non-randomized feasibility study in babies born at a gestational age 28 weeks or greater at the Royal Women’s Hospital. We plan to provide respiratory support to the newborn infant with the umbilical cord intact. The umbilical cord will then be clamped after physiologic changes indicating a successful neonatal adaption has begun, based on end tidal carbon dioxide monitoring. Specifically, umbilical cord clamping will be delayed for 60 seconds after the newborn’s end-tidal carbon dioxide is measured at >15 mmHg. If the infant requires no respiratory support and is breathing/crying well, cord clamping will occur as early as 2 minutes. The maximum time of delayed umbilical cord clamping will be 5 minutes after birth.

The clinical team in charge of the care for the baby will use a portable BABY-DUCC warming mattress allowing the evaluation and initiation of respiratory support to occur next to the mother. Specifically, the portable BABY-DUCC warming mattress will be equipped to provide heat to the newborn (chemical heating packs or electric warming mattress) and we will have a dedicated study “respiratory support pole” with the ability to provide blended oxygen, CPAP, positive pressure ventilation, heated and humidified gas, and suction. We will monitor and record end tidal carbon dioxide, tidal volume, pulse, and saturation of peripheral oxygenation using the NM3 Respiratory Profile Monitor (Phillips Healthcare, Massachusetts, USA), heart rate via electrocardiographic electrodes or portable ultrasound machine (GE Venue 50, Illinois, USA), and a high definition audio/video recording of the events (GoPro Hero3, California, USA). All physiologic information will be converted from analog to digital signal and recorded at 100 Hz using a custom built software program called the BABY-DUCC Data Acquisition System by the Royal Women’s Biomedical Engineering department which presents the data in graphical and table form for analysis.

In addition to the standard medical staff attending the deliveries, two dedicated members of the research team will be present at each delivery to review the study protocol with all the clinical staff in the delivery room (including staff looking after the mother), confirm with the clinical teams that there are no increased risks to the mother’s or baby’s health that would preclude attempting the BABY-DUCC protocol, set up the study materials, and carry out the study protocol. Apart from initiating respiratory support, if needed, prior to umbilical cord clamping, babies will be supported according to the Australian/RWH Neonatal Resuscitation guidelines.
Intervention code [1] 297367 0
Treatment: Other
Comparator / control treatment
None, feasibility trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301337 0
To determine if it is feasible to perform baby-directed umbilical cord clamping (BABY-DUCC) or providing respiratory support with an intact placental circulation and clamping the umbilical cord after successful neonatal adaption has begun in babies born at 28 weeks or greater gestational age.

Feasibility will be assessed by compliance with protocol and assessment of physiologic measurements made during the study period (HR, SpO2, respiratory status, APGAR scores, maternal bleeding including quantification of post partum blood loss and the need for treatment for PPH), and maternal complications, such as infection. We will also debrief with the maternal and neonatal treatment teams to assess for any additional issues. Physiologic measurements will be made by pulse oximetry, ECG electrodes, bedside ultrasound machine, written records by the clinical and research teams (including medical records prior to discharge), and video review where available.
Timepoint [1] 301337 0
In the first 5 minutes after delivery
Secondary outcome [1] 332319 0
1) To study the safety of baby-directed umbilical cord clamping on infants born at 28 weeks or greater gestational age. specifically reviewing available medical records for evidence of neonatal infection, maternal infection, temperature on admission to the NICU, haematocrit levels, number of transfusions, bilirubin levels, treatment for jaundice and polycythaemia, feeding issues, necrotising enterocolitis, intraventricular haemorrhage, echocardiography results, need for inotropic support, intubations, days of mechanical ventilation, or other relevant morbidities.

Timepoint [1] 332319 0
Prior to discharge from the hospital
Secondary outcome [2] 332320 0
2) To study the feasibility of the BABY-DUCC protocol (including video review when available).

Feasibility will be assessed by compliance with protocol and assessment of physiologic measurements made during the study period (HR, SpO2, respiratory status, APGAR scores, maternal bleeding including quantification of post partum blood loss and the need for treatment for PPH), and maternal complications, such as infection. We will also debrief with the maternal and neonatal treatment teams to assess for any additional issues. Physiologic measurements will be made by respiratory function monitor, pulse oximetry, ECG electrodes, bedside ultrasound machine, written records by the clinical and research teams (including medical records prior to discharge), and video review where available.
Timepoint [2] 332320 0
In the first minutes after birth
Secondary outcome [3] 332321 0
3) To determine if it is feasible to measure and record an accurate HR (via ECG electrodes or portable ultrasound) in babies receiving BABY-DUCC prior to umbilical cord clamping.

Feasibility will be assessed by compliance with protocol and assessment of physiologic measurements made during the study period (EtCO2, tidal volume, HR, SpO2, respiratory status, APGAR scores, maternal bleeding including quantification of post partum blood loss and the need for treatment for PPH), and maternal complications, such as infection. We will also debrief with the maternal and neonatal treatment teams to assess for any additional issues. Physiologic measurements will be made by respiratory function monitor, pulse oximetry, ECG electrodes, bedside ultrasound machine, written records by the clinical and research teams (including medical records prior to discharge), and video review where available.
Timepoint [3] 332321 0
In the delivery room
Secondary outcome [4] 332322 0
4) To observe the HR of apnoeic newborns with intact placental circulation. HR monitored via pulse oximetry, ECG, or portable ultrasound. Respiratory status monitored with video recording and respiratory function monitor as available.
Timepoint [4] 332322 0
Continuous monitoring in the delivery room for at least 5 minutes after birth if no respiratory support is needed after birth and at least 10 minutes after birth if any respiratory support is needed after birth.
Secondary outcome [5] 332323 0
5) To measure saturation of peripheral oxygen in babies receiving respiratory support with an intact umbilical cord assessed via pulse oximeter.
Timepoint [5] 332323 0
Continuous monitoring in the delivery room for at least 5 minutes after birth if no respiratory support is needed after birth and at least 10 minutes after birth if any respiratory support is needed after birth.
Secondary outcome [6] 332324 0
6) To describe umbilical cord arterial and venous blood gas results in babies receiving BABY-DUCC.
Timepoint [6] 332324 0
Umbilical arterial and venous blood gases will be obtained within 15 minutes of delivering the placenta after birth.

Eligibility
Key inclusion criteria
Inborn babies born at greater or equal to 28 weeks gestation are eligible for this study. The research team will obtain permission to approach the expecting family from the treating maternal clinicians (e.g. midwife, obstetrician, and anaesthesiologist) responsible for the care of the expecting mother. Antenatal consent will then be sought and obtained from the parents prior to enrolment.
Minimum age
No limit
Maximum age
0 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be excluded from analysis if they have a known congenital abnormality compromising cardiorespiratory function including congenital diaphragmatic hernia, hydrops fetalis, cyanotic congenital heart disease, and airway anomalies compromising mask ventilation. Infants who are not medicare eligible will be excluded.

If the maternal treatment team feels that the mother is at high risk for obstetric complications that may be exacerbated by the study intervention prior to delivery or during the study intervention, the study intervention will be immediately discontinued, the umbilical cord will be clamped and the baby will be moved to the standard radiant warmer bed. Neonatal support will be continued according to the Australian/RWH Neonatal Resuscitation guidelines. Potential maternal obstetric complications that may be criteria for exclusion from the study at the discretion of the maternal care team include abnormal placentation, suspected placental abruption, suspected uterine rupture, significant antenatal blood loss, coagulopathy, and previous history of significant blood loss.

In the event of dichorionic diamnionic twins the research team may enrol the presenting twin at the discretion of the maternal care team. The second twin will not be enrolled because of the increased risk of post-partum haemorrhage. Monochorionic twins will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Infants will be recruited over a period of 12 months. Approximately another 3 months will be required to collect hospital data on all infants enrolled. Medical data on each infant will be collected on Case Report Forms (Patient Data Form, Baby-Directed Umbilical Cord Clamping Feasibility Study). Non-identifiable study numbers will be assigned to each patient. De-identified information will be collected via the BABY-DUCC Data Acquisition System and audio, video recordings. Non-identifiable information will then be entered into an excel database for analysis. Non-identifiable patient information will be maintained in a password protected computer, which will be stored in a locked office in accordance with RWH R&E standards.

The primary objective for this study to determine if baby-directed umbilical cord clamping (clamping the umbilical cord after successful neonatal adaption has begun) is feasible and safe. The study is descriptive in nature. We plan on describing the neonatal transition of the infants in this study based on our physiologic monitoring, including measuring heart rate, saturation of peripheral oxygen, end-tidal carbon dioxide, tidal volume in the first minutes of life. We plan to record the respiratory effort of the infant, when the end-tidal CO2 goal is reached, when the umbilical cord is clamped, and describe the changes in the HR, SpO2, ECO2, and tidal volume after umbilical cord clamping.

Recruitment
Recruitment status
Completed
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] 7595 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 15494 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295808 0
Government body
Name [1] 295808 0
National Health And Medical Research Council Program Grant
Address [1] 295808 0
16 Marcus Clarke Street
Canberra, ACT 2601
Country [1] 295808 0
Australia
Funding source category [2] 295809 0
Hospital
Name [2] 295809 0
The Royal Women's Hospital
Address [2] 295809 0
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [2] 295809 0
Australia
Primary sponsor type
Individual
Name
Douglas Blank
Address
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 294649 0
Individual
Name [1] 294649 0
Peter Davis
Address [1] 294649 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [1] 294649 0
Australia
Secondary sponsor category [2] 294650 0
Individual
Name [2] 294650 0
Omar Kamlin
Address [2] 294650 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [2] 294650 0
Australia
Secondary sponsor category [3] 294651 0
Individual
Name [3] 294651 0
Jennifer Dawson
Address [3] 294651 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [3] 294651 0
Australia
Secondary sponsor category [4] 294652 0
Individual
Name [4] 294652 0
Sue Jacobs
Address [4] 294652 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [4] 294652 0
Australia
Secondary sponsor category [5] 294653 0
Individual
Name [5] 294653 0
Marta Thio
Address [5] 294653 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [5] 294653 0
Australia
Secondary sponsor category [6] 294654 0
Individual
Name [6] 294654 0
Kevyn Nyland
Address [6] 294654 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [6] 294654 0
Australia
Secondary sponsor category [7] 294655 0
Individual
Name [7] 294655 0
Stefan Kane
Address [7] 294655 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [7] 294655 0
Australia
Secondary sponsor category [8] 294656 0
Individual
Name [8] 294656 0
Alicia Dennis
Address [8] 294656 0
The Royal Women's Hospital
Newborn Research
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country [8] 294656 0
Australia
Secondary sponsor category [9] 294657 0
Individual
Name [9] 294657 0
Graeme Polglase
Address [9] 294657 0
The Ritchie Centre, The Hudson Institute
Department of Obstetrics and Gynaecology, Monash University
27-31 Wright Street
Clayton, VIC 3168
Country [9] 294657 0
Australia
Secondary sponsor category [10] 294658 0
Individual
Name [10] 294658 0
Stuart Hooper
Address [10] 294658 0
The Ritchie Centre, The Hudson Institute
Department of Obstetrics and Gynaecology, Monash University
27-31 Wright Street
Clayton, VIC 3168
Country [10] 294658 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297096 0
The Royal Women's Hospital Human Research and Ethics Committee
Ethics committee address [1] 297096 0
The Royal Women's Hospital
Newborn Research
Locked Bag 300
Cnr of Grattan Street and Flemington Road
Parkville, VIC 3052
Ethics committee country [1] 297096 0
Australia
Date submitted for ethics approval [1] 297096 0
02/11/2016
Approval date [1] 297096 0
31/01/2017
Ethics approval number [1] 297096 0
16/34

Summary
Brief summary
Using the PICO format (participants, intervention, comparison, outcome):

P: In babies greater than or equal to 28 weeks gestational age at birth
I: can umbilical cord clamping be delayed for 60 seconds after newborn end-tidal carbon dioxide levels exceed >15 mmHg (baby-directed umbilical cord clamping)?
C: no comparator
O: The primary outcome is adherence to study protocol and evaluation of protocol safety.

The purpose of this non-randomized feasibility study is to gain experience providing baby-directed umbilical cord clamping (BABY-DUCC) in newborn infants born at 28 weeks or later immediately after birth. BABY-DUCC is delaying umbilical cord clamping after birth to maintain placental circulation and gas exchange and provide respiratory support (if indicated) until lung aeration and pulmonary gas exchange has begun indicating successful neonatal adaption after delivery.

This will be a single centre non-randomized feasibility study in babies born at a gestational age of 28 weeks or later at the Royal Women’s Hospital. We plan to provide respiratory support to the newborn infant with the umbilical cord intact. The umbilical cord will then be clamped after physiologic changes indicating a successful neonatal adaption has begun, based on end tidal carbon dioxide monitoring. Specifically, umbilical cord clamping will be delayed for 60 seconds after the newborn’s end-tidal carbon dioxide is measured at >15 mmHg.

The clinical team in charge of the care for the baby will use a portable BABY-DUCC warming mattress allowing the evaluation and initiation of respiratory support to occur next to the mother. Specifically, the portable BABY-DUCC warming mattress will be equipped to provide heat to the newborn (chemical heating packs or electric warming mattress) and a dedicated study “respiratory support pole” with the ability to provide blended oxygen, CPAP, positive pressure ventilation, heated and humidified gas, and suction. We will monitor and record end tidal carbon dioxide, tidal volume, pulse, and saturation of peripheral oxygenation using the NM3 Respiratory Monitor, heart rate via electrocardiographic electrodes or portable ultrasound machine, and a high definition audio/video recording of the events. All physiologic information will be converted from analog to digital signal and recorded at 100 Hz using a custom built software program called the BABY-DUCC Data Acquisition System which presents the data in graphical and table form for analysis.

In addition to the standard medical staff attending the deliveries, two dedicated members of the research team will be present at each delivery to review the study protocol with all the clinical staff in the delivery room (including staff looking after the mother), confirm with the clinical teams that there are no increased risks to the mother’s or baby’s health that would preclude attempting the BABY-DUCC protocol, set up the study materials, and carry out the study protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72962 0
Dr Douglas Blank
Address 72962 0
The Royal Women's Hospital
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country 72962 0
Australia
Phone 72962 0
+61422305487
Fax 72962 0
Email 72962 0
douglas.blank@thewomens.org.au
Contact person for public queries
Name 72963 0
Dr Douglas Blank
Address 72963 0
The Royal Women's Hospital
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country 72963 0
Australia
Phone 72963 0
+61422305487
Fax 72963 0
Email 72963 0
douglas.blank@thewomens.org.au
Contact person for scientific queries
Name 72964 0
Dr Douglas Blank
Address 72964 0
The Royal Women's Hospital
Cnr Grattan Street & Flemington Road
Locked Bag 300
Parkville, VIC 3052
Country 72964 0
Australia
Phone 72964 0
+61422305487
Fax 72964 0
Email 72964 0
douglas.blank@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary