None listed
Conditions
Brief summary
Deferred (delayed) cord clamping for at least 60 seconds improves survival in very preterm infants. However, some infants require positive pressure ventilation to establish breathing in the first minutes after birth. For these infants, the cord is often clamped early, therefore they miss out on the benefits of deferred cord clamping. Furthermore, positive pressure ventilation may injure the fragile preterm lung. Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. We hypothesise that the provision of nasal high-flow prior to cord clamping may support and stimulate breathing, therefore allowing deferred cord clamping to occur and limiting positive pressure ventilation, improving outcomes. In this single-centre pilot feasibility trial, preterm infants born 26-31+6 weeks’ gestation will receive nasal high-flow during deferred cord clamping. We aim to study the feasibility of providing nasal high-flow prior to cord clamping in 20 infants with respect to 1) acceptability to clinicians and 2) practical application. We will also study clinical and physiological outcomes in infants receiving nasal high-flow during deferred cord clamping. These pilot data will help establish feasibility for a larger randomised controlled trial, and inform the primary outcome and sample size for this definitive trial.
Interventions
Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. Nasal high-flow is currently used in preterm infants with respiratory distress soon after birth. Nasal high-flow will be provided to very preterm infants immediately after birth, aiming for a minimum duration of 60 and maximum duration of 120 seconds if good tone and respirations, consistent with local guidelines at the Royal Women's Hospital.
A research team member (neonata
Nasal high-flow therapy (nasal high-flow) provides heated, humidified, blended air and oxygen via two small nasal prongs. Nasal high-flow is currently used in preterm infants with respiratory distress soon after birth. Nasal high-flow will be provided to very preterm infants immediately after birth, aiming for a minimum duration of 60 and maximum duration of 120 seconds if good tone and respirations, consistent with local guidelines at the Royal Women's Hospital. A research team member (neonatal consultant or fellow) will be administering the intervention (applying the high flow).
Sponsors
Royal Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 1 Hours
Healthy volunteers
No
Inclusion criteria
Very preterm infants born 26-31+6 weeks’ gestation born at the Royal Women’s Hospital, where prospective, written consent has been obtained from the parent/legal guardian.
Exclusion criteria
• Contraindication to deferred cord clamping, including monochorionic twin pregnancy, large antepartum haemorrhage, vasa praevia or placental abruption, general anaesthetic, cord prolapse • Contraindication to nasal high-flow (congenital diaphragmatic hernia, abdominal wall defect, nasal abnormality, craniofacial abnormality involving nose/mouth, cyanotic congenital heart disease)
Outcome results
None listed