None listed
Conditions
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.
Interventions
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 c
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.
Sponsors
Douglas Blank
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
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.
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.
Outcome results
None listed