None listed
Conditions
Brief summary
The study aims to evaluate whether, in infants greater than or equal to 32 weeks gestation who require resuscitation at birth, the initiation of breathing either prior to or after umbilical cord clamping affects cerebral blood pressure, blood flow and oxygenation. Large changes in these parameters are potentially injurious and have been seen in animal models following immediate cord clamping. This is a sub-study nested within the Baby-DUCC Physiology Randomised Trial (ACTRN12618000621213). All infants will follow the protocol for the Baby-DUCC Physiology RCT for enrolment, randomisation and follow-up. We present the CHOP study as a sub-study because (a) it addresses a separate, distinct hypothesis using physiological measurements not performed within the BabyDUCC trial, and (b) it has additional inclusion criteria, meaning only a subgroup of infants in the BabyDUCC trial will be eligible. If the infant requires resuscitation 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 blood pressure, cerebral blood flow and cerebral oxygenation after birth.
Interventions
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 monitoring equipment and collection of 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. 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.
Sponsors
The Royal Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 1 Hours
Healthy volunteers
No
Inclusion criteria
Inclusion criteria are as per the BabyDUCC trial (ACTRN12618000621213). 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 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. In addition, for this sub-study the following additional inclusion criteria apply: - Availability of additional research resources to conduct the study measurements - antenatal consent for the measurements detailed above (blood pressure, doppler ultrasound, near infrared spectroscopy).
Exclusion criteria
Exclusion criteria are as per the BabyDUCC trial (ACTRN12618000621213). 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.
Outcome results
None listed