None listed
Conditions
Brief summary
Preterm babies with breathing troubles are routinely supported by the use of continuous positive airway pressure (CPAP) via nasal prongs that require taping to the infant’s face and a bonnet to maintain an adequate seal and to keep the prongs in position. This can restrict care, parent-infant cuddles and breast feeding. The prongs also occlude the nose and sometimes cause damage to the nasal septum. Weaning an infant from CPAP may take weeks or months. This is a randomised controlled trial of 2 methods of weaning CPAP support (abrupt or gradual), combined with the use of Heated Humidified High Flow Nasal Cannula (HHFNC) devices or not, making four arms / groups. The purpose of the study is to determine which method of weaning from CPAP is most effective at reducing the length of hospital stay, facilitating infant suck feeding and parent-infant interaction and reducing the intensity of nursing care.
Interventions
2x2 factorial design:
Group 1:Abrupt weaning from nCPAP to HHHFNC - infant is taken OFF nCPAP and put onto HHHFNC with initial flow rate titrated to deliver pressure initially produced on nCPAP, then gradually decreasing flow rate at increments of 1litre per min at the discretion of medical team. Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria
2x2 factorial design: Group 1:Abrupt weaning from nCPAP to HHHFNC - infant is taken OFF nCPAP and put onto HHHFNC with initial flow rate titrated to deliver pressure initially produced on nCPAP, then gradually decreasing flow rate at increments of 1litre per min at the discretion of medical team. Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial. Group 2: Abrupt weaning from nCPAP without HHHFNC - infant is taken OFF nCPAP and put into crib air/oxygen (<25%) or low flow nasal cannula oxygen if required (<1L/min). Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial. Group 3: Gradual weaning from nCPAP to HHHFNC – infant alternates between time ON and OFF nCPAP. HHHFNC is given during OFF periods with flow rate titrated to deliver pressure initially produced on nCPAP, gradually increasing HHHFNC time by 1h increments and/or according to infant stability until nCPAP can be stopped completely. Group 4: Gradual weaning from nCPAP without HHHFNC – infant alternates between time ON and OFF nCPAP by alternating between time on and off CPAP as the infant tolerates, gradually increasing time OFF until nCPAP can be stopped completely.
Sponsors
RPA Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
24 Weeks to 30 Weeks
Healthy volunteers
No
Inclusion criteria
All babies born less than 30 completed weeks gestational age, AND 1. Clinically stable on less than or equal to 5cm H2O nasal continuous positive airway pressure (nCPAP) with mouth closed OR 2. Clinically stable on nCPAP (any level) but tolerating 6 hours with mouth open, OR 3. Clinically stable on nCPAP (any level) and tolerating 6 hours OFF nCPAP
Exclusion criteria
Infection defined as positive blood or cerebrospinal fluid culture within the previous 48 hours Major congenital or chromosomal abnormalities Severe neurologic insults or neuromuscular disease
Outcome results
None listed